[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leiomyosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leiomyosarcoma":1042},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,40,61,88,125,160,184,210,237,318,337,361,406,437,468,487,511,532,939,960,994,1017],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":23,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100433512",false,"NCT04925089","Localized Leiomyosarcoma Biomarker Protocol","Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy","Inclusion Criteria:\n\n* Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum\n* Grade 2 or 3, or high-grade LMS\n* Tumor size \\>5 cm in greatest dimension\n* Primary tumor amenable to complete resection\n* There is no age requirement\n* Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy\n* If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered\n* Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H\\&E stained slide) from diagnostic or pre-treatment biopsy available for study research","ALL",{"count":17,"type":18},40,"ESTIMATED","OBSERVATIONAL","* Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS).\n* Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.\n* Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.\n* Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival\n* Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.\n* Circulating tumor DNA (ctDNA) is present in blood of patients with advanced\u002Fmetastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence.\n* A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.",[22],"Leiomyosarcoma",[24,25,26],"ctDNA","radiomics","biomarker","RECRUITING","2026-07-01",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2023-04-26",{"date":35,"type":18},"2026-11",{"name":37,"class":38},"University of Michigan Rogel Cancer Center","OTHER",3,{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":48,"conditions":49,"keywords":50,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100489459","NCT05653388","Metastatic Leiomyosarcoma Biomarker Protocol","Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy","Inclusion Criteria:\n\n* Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement\n* Receiving first-line chemotherapy with doxorubicin- based or gemcitabine\u002Fdocetaxel\n* Target lesions per RECIST 1.1\n* Optional archival tumor tissue including 1 H\\&E-stained slide and unstained tumor tissue \\[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample\\] available for study research",{"count":47,"type":18},200,"Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced\u002Fmetastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and chemotherapy, and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.",[22],[24,51,25],"Biomarker","2026-06-23",{"date":54,"type":31},"2026-06-24",{"date":56,"type":31},"2022-12-22",{"date":58,"type":18},"2026-12",{"name":37,"class":38},11,{"id":62,"slug":4,"hasResults":10,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100643791","NCT07633756","A Phase 1b, Open-Label Study Of REC-617, A Selective CDK7 Inhibitor, In Patients With Metastatic Or Unresectable RB1-Negative Leiomyosarcoma After Prior Systemic Therapy","Eligibility Criteria A. Disease Characteristics\n\n* Histologically confirmed leiomyosarcoma (any site of origin).\n* RB1-negative tumor, as assessed by immunohistochemistry (IHC) with a cutoff of 0% versus any expression Participants will have measurable diseases by RECIST 1.1. Previously ablated\u002F radiated\u002Ftreated areas can only be counted towards measurable disease if there is unequivocal progression after directed therapy.\n* Participant will have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases, as confirmed by a radiologist, if appropriate, and as deemed safe by the Investigator. If there is only one target lesion per RECIST 1.1 which is accessible to biopsy, this lesion should be at least 2cm.\n\nB. Prior and Current Therapy Requirements\n\n* At least one prior line of systemic therapy. C. Participants Characteristics\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of REC-617 in Participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤ 2 (Karnofsky ≥60%,).\n* Life expectancy of \\>3 months, as determined by the investigator.\n* Ability to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document and comply with study procedures.\n\nD. Organ and Marrow Function Requirements\n\nParticipants will have adequate organ and marrow functions as defined below:\n\nHemoglobin ≥8.5 g\u002FdL. Absolute neutrophil count ≥1,000\u002FmcL Platelets ≥150,000\u002FmcL, no platelet transfusion within 7 days prior to screening visit Total bilirubin ≤ institutional upper limit of normal (ULN) (except Participants with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN INR ≤1.5 except for Participants on oral anticoagulants Creatinine clearance ≥60 mL\u002Fmin based on the Cockcroft-Gault equation or method standard to institution E. Viral and Infectious Disease Requirements\n\n* Participants may not have active or chronic infections with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) F. CNS and Cardiac Requirements\n* Participants with asymptomatic treated CNS lesions who have completed treatment ≥30 days prior with documented stability on imaging and are on a stable steroid dose are eligible.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, Participants should be class 2B or better.\n* Participants should not have a QTcF \\>470 msec or history of torsades de pointes or history of congenital long QT syndrome.\n\nG. Reproductive\u002FContraception Requirements\n\nThe effects of REC-617 on the developing human fetus are unknown. For this reason and because CDK7 inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men will agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  * Participants are eligible to participate if they agree to use 2 methods of contraception, approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\nMen and women treated or enrolled on this protocol will also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of REC-617 administration.\n\nExclusion Criteria A. Concurrent Treatments and Investigational Agents\n\n* Participants who are receiving any other investigational agents or have received any other investigational agent within 3 weeks prior to enrollment.\n* Current enrollment in another clinical study unless it is non-interventional or the follow-up period of an interventional study.\n* Prior treatment with radiotherapy (including radio-labeled spheres and\u002For cyberknife, hepatic arterial embolization (with or without chemotherapy) or cryotherapy\u002Fablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.\n* Received medications known to prolong QTc within 5 half-lives before the first dose of the study treatment. List of medications that prolong QTc can be obtained from crediblemeds.org.\n* Administration of a live vaccine within 28 days of starting study treatment and for up to 1 month after the final dose of study treatment or anticipation that such vaccine will be required during the study. Note: mRNA-based vaccines for COVID-19 are allowed as well as inactivated flu vaccines.\n* Has had or is scheduled to have major surgery \\\u003C28 days prior to the first dose of study treatment.\n\nB. Disease or Cancer-Related Exclusions\n\n* Active concurrent second malignancy within 2 years of trial enrollment. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Examples include non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer.\n* Unresolved or unstable toxic side-effects of prior anticancer therapy, except fatigue, alopecia, infertility, peripheral neuropathy, or those relating to palliative radiotherapy within 6 weeks prior to first dose of study treatment will have resolved to Grade 1 or less.\n\nC. Other comorbidities affecting participation\n\n* Active gastrointestinal bleeding.\n* Evidence of severe or uncontrolled systemic disease or psychiatric illness that, in the investigator's judgment, would limit safety or compliance.\n* Impaired gastrointestinal absorption\n* History of allergic reactions to compounds like REC-617. D. Transplant History\n* Prior organ or allogeneic stem-cell transplantation","18 Years",{"count":68,"type":18},15,"INTERVENTIONAL",[71],"PHASE1","To learn if the study drug REC-617 can help to control LMS. The safety of REC-617 will also be studied.",[74,75,76,77,22],"Phase 1b","Open Label","REC-617","RB1-Negative","NOT_YET_RECRUITING","2026-06-19",{"date":54,"type":31},{"date":82,"type":18},"2026-10-19",{"date":84,"type":18},"2031-12-26",{"name":86,"class":38},"M.D. Anderson Cancer Center",1,{"id":89,"slug":4,"hasResults":10,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":69,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100576736","NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate",{"count":96,"type":18},146,[71],"The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[100,101,102,103,104,105,106,107,108,109,22,110,111,112,113],"Solid Tumours","Sarcoma","HNSCC","Non Small Cell Lung Cancer","NSCLC","Colorectal Cancer (CRC)","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma (LMS)","Gastric Cancer (GC)","Gastric Cancer Adenocarcinoma Metastatic","Gastric \u002F Gastroesophageal Junction Adenocarcinoma","2026-06-09",{"date":116,"type":31},"2026-06-11",{"date":118,"type":31},"2025-01-23",{"date":120,"type":18},"2028-09",{"name":122,"class":123},"Epkin","INDUSTRY",10,{"id":126,"slug":4,"hasResults":10,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":69,"phases":133,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":87},"100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":132,"type":18},25,[134],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[137,138,139,140,141,142,143,144,145,22,146,147,148,149,150],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Rhabdomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":153,"type":31},"2026-06-05",{"date":155,"type":31},"2026-05-01",{"date":157,"type":18},"2028-05-01",{"name":159,"class":38},"University of California, Irvine",{"id":161,"slug":4,"hasResults":10,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":69,"phases":168,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100632687","NCT07516925","A Study of Ivonescimab in People With Leiomyosarcoma","Vonescimab for the Treatment of Previously Treated Advanced or Unresectable Leiomyosarcoma - a Phase II Trial","Inclusion Criteria:\n\n* Male or female age ≥ 18 years at the time of informed consent\n* Subjects must have a histologically confirmed unresectable\u002Fmetastatic LMS\n* Be willing and able to provide written informed consent\u002Fassent for the trial\n* Be willing to comply with treatment protocol\n* Adequate performance status: ECOG 0 - 2\n* Subjects must have had at least 1 but not more than 3 prior lines of systemic therapy for their LMS. Patients who decline the standard of care first-line systemic therapy will be eligible for this trial. Prior adjuvant therapy will not count provided it was completed more than 6 months previously.\n* Patients who were treated with radiotherapy must have completed radiation therapy at least 2 weeks before the study drug administration.\n* Patients who were treated with chemotherapy or any investigational therapies or other anti-cancer agent, if eligible, must have been completed at least 3 weeks or at least 5 half-lives (whichever is longer, but no less than 3 weeks) before the study drug administration. All AEs must be ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline. Patients who were treated with estrogen modulating therapies (aromatase inhibitors, tamoxifen, GnRH agonists etc.) must have been treated at least 2 weeks prior to study drug administration.\n* Participants must have sufficient archival tumor tissue available (most recently procured sample where tissue is available) for research purposes. If archival tumor tissue is insufficient, a pre-treatment research biopsy will be optional but strongly encouraged, if safe and feasible, in the opinion of the Investigator. If biopsy is not feasible and no sufficient archival tissue is available, discussion is required with the Principal Investigator.\n* Presence of measurable disease per RECIST v1.1. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and\u002For pathologically documented tumor progression in that lesion prior to enrollment.\n* Adequate Organ Function:\n\n  a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n\nii. Platelet count ≥ 100 × 10\\^9\u002FL\n\niii. Hemoglobin ≥ 9.0 g\u002FdL\n\nb. Kidneys:\n\ni. Creatinine clearance\\* (CrCL) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥30 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR) CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).\n\nii. Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n\nc. Liver:\n\ni. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN\n\nii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastases, AST and ALT ≤ 5 × ULN\n\n* Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n* Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab.\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab.\n\nExclusion Criteria:\n\n* Prior therapy with an anti PD1\u002FPDL1 inhibitor and\u002For VEGF inhibitor (including multi-tyrosine kinase inhibitors with VEGF inhibition such as pazopanib\u002Fcabozantinib\u002Fsunitinib).\n* History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.\n* Evidence of clinically significant immunosuppression such as the following: o Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease o Concurrent opportunistic infection o Receiving systemic immunosuppressive therapy (\\> 2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for steroid use, chronic\u002Factive low dose steroid use may be permitted at the discretion of the principal investigator. The dose of steroid allowed in this setting is also at the discretion of the principal investigator. (Use of inhaled or topical steroids is permitted.)\n* Major surgical procedures or serious trauma within 4 weeks prior to randomization, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:\n\n  1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  2. Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed)\n  3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n\nPoorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n\n* Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to randomization, however the following will be allowed:\n\n  1. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n  2. Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n* History of major diseases before randomization, specifically:\n\n  1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  2. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomization\n  3. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to randomization\n  4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomization\n  5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization\n* Imaging during the screening period shows that the patient has:\n\n  1. Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor invading organs (heart, trachea, esophagus, central bronchi \\[not including segmental bronchi\\]) or if there is a risk of esophagotracheal or esophagopleural fistula in the opinion of the investigator.\n  2. Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.\n* Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease.\n\nNote: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent)\n\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned randomization, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed.\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to randomization. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n* Patient is breastfeeding or plans to breastfeed during the study.",{"count":167,"type":18},20,[169],"PHASE2","The purpose of this study is to find out if Ivonescimab is an effective and safe treatment that causes few or mild side effects for people with advanced\u002Funresectable leiomyosarcoma.",[22],[173,174],"Ivonescimab","26-011",{"date":176,"type":31},"2026-06-03",{"date":178,"type":31},"2026-04-01",{"date":180,"type":18},"2029-04",{"name":182,"class":38},"Memorial Sloan Kettering Cancer Center",7,{"id":185,"slug":4,"hasResults":10,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":69,"phases":193,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":209},"100364933","NCT04031677","Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma","A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)","STRASS2","1. STRASS 2\n\n   Inclusion Criteria:\n   * Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.\n   * LMS:\n\n     * Any grade LMS can be included\n     * Minimum size of LMS tumor should be 5 cm\n   * LPS:\n\n     * Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.\n     * All grade 3 DDLPS can be included.\n     * DDLPS with confirmed grade 2 on biopsy can be included when:\n\n       * The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de Lutte Contre Le Cancer), and clear necrosis on imaging (whether or not present on the biopsy).\n       * The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)\n     * Unifocal tumour\n     * Resectable tumour: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only an R2 resection is feasible.\n     * Criteria for non-resectability are:\n     * Involvement of the superior mesenteric artery, aorta, coeliac trunk and\u002For portal vein\n     * Involvement of bone\n     * Growth into the spinal canal\n     * Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium\n     * Infiltration of multiple major organs like liver, pancreas and or major vessels\n     * Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging. CT thorax abdomen pelvis with IV contrast is the preferred imaging modality. In case of any contra-indications (medical or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen \\& pelvis\n     * Collection of tumour tissue for central pathology review is mandatory.\n     * For patients with LMS: if there is not enough tissue for assessing the grading, this is acceptable.\n     * If tumour tissue is not available for the central pathology review, patient will not be eligible.\n     * If the biopsy was not done or the FFPE of the biopsy not available but at least 10 unstained slides or one pathological block are available for the central review, that will be considered as acceptable.\n     * For the biopsy if fine needle aspiration (FNA) is performed instead of core needle biopsy (CNB) recommended by the standard guidelines, please contact the EORTC medical monitors for further evaluation.\n     * Collection of tumour tissue and blood samples for translational research is mandatory.\n     * In case there is not enough tissue for TR, a new biopsy is not required and if the patient fulfils all other eligibility criteria, he\u002Fshe will be eligible.\n     * If the blood samples are not collected, patient will not be eligible.\n     * If the patient refuses the collection of biomaterial for TR, patient will not be eligible even if he\u002Fshe fulfils all other eligibility criteria\n     * ≥ 18 years old (no upper age limit)\n     * WHO performance status ≤ 2\n     * Adequate haematological and organ function\n     * American Society of Anaesthesiologist (ASA) score \\\u003C 3\n     * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.\n\n   Note: a woman is considered of childbearing potential, i.e., fertile, if she is following menarche. She remains of childbearing potential until she becomes post-menopausal or permanently sterile.Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 consecutive months without menses, a single FSH measurement is insufficient.\n   * WOCBP in both arms should use highly effective birth control measures, during the study treatment period and for at least 6 months after the last dose of chemotherapy or date of surgery (except for women receiving chemotherapy with ifosfamide who should continue contraception until 1 year after last day of treatment). A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n   * For men in the experimental arm: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.\n   * Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and until 6months after the last study treatment.\n   * Before patient randomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\n   Exclusion criteria:\n   * Sarcoma originating from bone structure, abdominal or gynecological viscera\n   * Extension through the sciatic notch or across the diaphragm\n   * Metastatic disease\n   * Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour\n   * Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients\n   * Congestive heart failure\n   * Angina pectoris\n   * Myocardial infarction within 1 year before randomization\n   * Uncontrolled arterial hypertension defined as blood pressure ≥ 150\u002F100 mm Hg despite optimal medical therapy.\n\n   Note: in case of high blood pressure: 1) initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; 2) blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP \u002F DBP values from each blood pressure assessment must be ≤ 150\u002F90mmHg in order for a patient to be eligible for the study.\n   * Uncontrolled cardiac arrhythmia\n   * Previous treatment with maximum cumulative doses (450mg\u002Fm² Doxorubicin or equivalent 900mg\u002Fm² Epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones\n   * Active and uncontrolled infections\n   * Vaccination with live vaccines within 30 days prior to study entry\n   * Inflammation of the urinary bladder (interstitial cystitis) and\u002For obstructions of the urine flow.\n   * Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6prostate cancer.\n   * Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.\n   * Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.\n   * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial\n   * Known contraindication to imaging tracer and to MRI\n2. Selection criteria for STREXIT 2\n\n   * Patients with histologically proven primary resectable localized high-risk DDLPS or LMS of retroperitoneal space or infra-peritoneal spaces of pelvis (as described in the inclusion criteria of STRASS 2) and amenable to receive chemotherapy but for whom the list of eligibility criteria for the study is too restrictive (tumour grading not available, inadequate organ function, concomitant diseases)\n   * Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason.\n   * Patients enrolled in a Registry collecting data on primary RPS patients in the centres participating in STRASS 2 (e.g., RESAR) and who satisfy the above criteria.\n3. Selection criteria for preferences for neoadjuvant chemotherapy in STRASS 2 substudy\n\nAll patients recruited to STRASS 2 in participating centres (Australia +\u002F- international sites) that are able to read, comprehend and write in English at a sufficient level to complete study materials.",{"count":192,"type":18},250,[194],"PHASE3","This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.\n\nAfter confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.",[197,198,22],"Retroperitoneal Sarcoma","Liposarcoma","2026-05-20",{"date":201,"type":31},"2026-05-22",{"date":203,"type":31},"2021-01-20",{"date":205,"type":18},"2028-04-21",{"name":207,"class":208},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",169,{"id":211,"slug":4,"hasResults":10,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":69,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100591043","NCT06975293","STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas","Open-label, Non-randomized, Multi-cohort, Phase 1b\u002F2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas","Key Inclusion Criteria:\n\n* Estimated life expectancy ≥ 3 months.\n* ECOG performance status 0 or 1.\n* Measurable disease according to RECIST v1.1 as assessed by the local site investigator\u002Fradiology.\n* Documented radiologic assessment of progression on the prior therapy before study entry.\n* Have adequate organ function.\n* Have the ability to swallow, retain, and absorb oral medication.\n\nInclusion Criteria (Phase 2 Monotherapy Cohorts):\n\n* Have histologic or cytologic confirmation of advanced sarcoma of the selected histologic subtype that is not amenable to local curative therapy. Participant must have received at least 2, but no more than 4 prior lines of systemic therapy.\n* Pre-treatment and on-treatment biopsy if medically feasible.\n\nKey Exclusion Criteria:\n\n* Pregnant and lactating women.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to first IMP administration.\n* Participants who have not recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline, according to NCI-CTCAE v5.0. Exceptions include: alopecia, Grade ≤ 2 neuropathy, and endocrine-related AEs Grade ≤ 2 who are stable on treatment or hormone replacement.\n* History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or the presence of ongoing pneumonitis\u002Finterstitial lung disease).\n* Clinically significant cardiovascular disease or condition.\n* Known active CNS metastases and\u002For leptomeningeal disease.",{"count":217,"type":18},107,[71,169],"This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab (anti- programmed cell death 1 \\[PD-1\\]) in advanced unresectable or metastatic tumors.\n\nThe Phase 2 Monotherapy part is an open-label, non-randomized, multicenter Simon's 2-stage design that investigates the safety, tolerability, and antitumor activity of STC-15 in participants with selected, relapsed sarcomas subtypes, dedifferentiated (DD) liposarcoma and leiomyosarcoma (uterine and non-uterine).",[221,101,22,108],"Solid Tumor",[223,224,225,226],"STC-15","Toripalimab","PD1","Checkpoint Combination","2026-04-17",{"date":229,"type":31},"2026-04-21",{"date":231,"type":31},"2025-05-05",{"date":233,"type":18},"2028-06-29",{"name":235,"class":123},"STORM Therapeutics LTD",6,{"id":238,"slug":4,"hasResults":10,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":69,"phases":246,"briefSummary":247,"conditions":248,"keywords":287,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":245,"type":18},28,[169],"The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,22,273,274,275,142,276,277,278,279,280,281,143,282,283,284,285,286],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Mesothelioma","Neuroblastoma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Hepatoblastoma","Fallopian Tube Neoplasms","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Neuroendocrine Tumors","Trophoblastic Tumor",[288,250,289,251,252,290,291,255,292,257,293,259,294,295,296,297,262,263,298,299,266,267,268,269,300,271,301,22,302,274,303,142,304,277,278,305,306,280,281,143,307,283,261,284,285,286],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Anal Cancer","Chromophobe Renal Carcinoma","Small Intestine Cancer","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Penile Cancer","Thyroid Cancer","Fallopian Tube Cancer","Vaginal Cancer","Gallbladder Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","Vulvar Cancer","Urethral Cancer","2026-04-10",{"date":310,"type":31},"2026-04-15",{"date":312,"type":31},"2024-07-16",{"date":314,"type":18},"2028-05",{"name":316,"class":38},"Instituto do Cancer do Estado de São Paulo",8,{"id":319,"slug":4,"hasResults":10,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":69,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":87},"100539790","NCT06308419","A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions","Inclusion Criteria:\n\n1. Patients must have histologically confirmed leiomyosarcoma or sarcoma with TSC2 or TSC1 loss-of-function mutations or deletions based on standard-of-care genomic testing.\n2. Sarcoma that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. One prior standard systemic therapy is required for leiomyosarcoma (LMS) Patients.\n3. Prior gemcitabine-based chemotherapy is allowed if the last dose of gemcitabine was given more than 12 months prior to the first dose of treatment on trial, there was no progression of disease while on treatment with gemcitabine, and there was intolerable toxicity.\n4. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n5. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of nab-sirolimus in combination with gemcitabine in patients \\\u003C18 years of age, children are excluded from this study.\n6. ECOG performance status ≤2 (Karnofsky ≥60%,).\n7. Life expectancy of \\>3 months, as determined by the investigator.\n8. Patients must have adequate organ and marrow function as defined below:\n\n   i. absolute neutrophil count ≥1,500\u002FmcL ii. platelets ≥100,000\u002FmcL iii. hemoglobin ≥9 gm\u002FdL iv. total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL) v. AST(SGOT)\u002FALT(SGPT) ≤2 × institutional ULN vi. eGFR (calculated by CKD-EPI) ≥ 60 mL\u002Fmin vii. Serum triglyceride \\\u003C300 mg\u002FdL viii. Serum cholesterol \\\u003C350 mg\u002FdL\n9. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n10. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For Participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n11. Patients with Human Immunodeficiency Virus (HIV) with a viral load \\\u003C400copies\u002FmL, no IADS-defining illness within 12 months of enrollment, and no CYP3A4 inducers or inhibitors in the antiretroviral treatment.\n12. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n13. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n14. The effects of nab-sirolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). Negative serum HCG will be required before study drug administration. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range).\n\n    History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Patient\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion:\n\n1. Patients who are receiving any other investigational agents or have received any other investigational agent within 3 weeks prior to enrollment.\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-sirolimus or gemcitabine.\n3. Use of strong inhibitors and inducers of CYP3A4 within the 7 days prior to receiving the first dose of nab-sirolimus. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole,cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 7 days prior to receiving the first dose of nab-sirolimus.\n4. Patients with active concurrent malignancy.\n5. Recent stroke or thromboembolic event (within 6 months) requiring anticoagulation that cannot be interrupted. Non-life threatening deep venous thrombosis on stable anticoagulation within 6 months is allowed.\n6. Active gastro-intestinal bleeding.\n7. Pre-existing thyroid abnormality is allowed provided thyroid can be controlled with medication.\n8. Prior treatment with radiotherapy (including radio-labeled spheres and\u002For cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy\u002Fablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.\n9. Uncontrolled diabetes mellitus as defined by HbA1c \\>8% despite adequate therapy.\n10. Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, that would significantly limit the ability to participate safely in this study.\n11. Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nab-sirolimus, breastfeeding should be discontinued if the mother is treated with nab-sirolimus. These potential risks may also apply to other agents used in this study.\n12. Prior treatment of sarcoma with mTOR inhibitors.\n13. Vulnerable populations will not be enrolled.",{"count":324,"type":18},18,[71],"To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas.",[22,328],"Soft-tissue Sarcomas","2026-02-24",{"date":331,"type":31},"2026-02-25",{"date":333,"type":31},"2024-08-14",{"date":335,"type":18},"2031-02-01",{"name":86,"class":38},{"id":338,"slug":4,"hasResults":10,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":69,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100287066","NCT03016819","Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)","A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma","APROMISS","Inclusion Criteria\n\n1. Written informed consent provided before any study-specific procedures are initiated. Subject must be able to understand and be willing to sign a written informed consent form.\n2. Male or female at least 18 years of age.\n3. a. Indication A - ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma. b. CLOSED Indication B - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone). c. CLOSED Indication C - SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma. d. CLOSED Indication D - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, and vascular origin).\n\n3\\. Open Indication E: Any sarcomas or other solid tumors 4. a. Indication A - ASPS: Subjects with or without prior therapy. b. Indications B - LMS: Subjects previously treated with at least one prior line of approved therapy. (New Recruitment Suspended) c. Indication C - SS: Subjects previously treated with at least one prior line of standard systemic therapy, including first-line anthracycline containing regimen (except if medically contraindicated or refused by subject). d. Indication D - LMS: Treatment of patients with metastatic or advanced leiomyosarcoma (LMS) who have failed at least one prior line of standard therapy and are ineligible for or refuse standard second-line therapy or are suitable for third- and further-line treatment. Patients must have received and progressed on prior therapy and have been treated any line with an anthracycline. e. Indication E: Any sarcomas or other solid tumors such as NSCLC, SCLC and Thyroid cancer etc.: Subjects exhausted SOC treatment or refuse for any SOC treatment.\n\n5\\. Show clinical or objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability within 6 months of enrollment (excluding ASPS subjects who have not received prior therapy).\n\n6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by CT or MRI scan of the chest, abdomen and pelvis (and other areas of disease) within 28 days prior to enrollment. 8. Life expectancy of at least 3 months.\n\n9\\. Females of childbearing potential must have a negative pregnancy test (by serum beta- HCG) within 7 days prior to the start of treatment.\n\n10\\. Female of childbearing potential must be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation), abstinent (at the discretion of the investigator), or agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 2 years. Males must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) at the discretion of the investigator. 11. Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 28 days of enrollment:\n\na. Total bilirubin \\\u003C the upper limit of normal (ULN), unless the patient has documented Gilbert's disease for which the total bilirubin should be \\\u003C 3. b. Alanine aminotransferase and aspartate aminotransferase \\\u003C 2.5 of the ULN (\\\u003C 5 x of ULN for subjects with liver involvement of their cancer) c. Amylase and lipase \\\u003C 1.5 x of ULN d. Serum creatinine \\\u003C 1.5 x of ULN e. Glomerular filtration rate \\> 30ml\u002Fmin\u002F1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula or creatinine clearance (CrCL) \\> 60 ml\u002Fmin (Cockcroft and Gault) or by 24 hour urine collection. f. International normalize ratio (INR) and the activated partial thromboplastin time (aPTT\u002FPTT) \\\u003C 1.5 x ULN. (Subjects who are therapeutically treated with an agent such LMWH or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists) g. Platelet count \\> 100,000 cells\u002Fmm3, hemoglobin \\> 9 g\u002FdL, absolute neutrophil count \\> 1,500 cells\u002Fmm3 h. Alkaline phosphatase limit \\\u003C2.5 x ULN (\\\u003C5 x ULN for subjects with liver involvement of their cancer) i. Urine protein \\\u003C 30 mg\u002FdL. If urine protein is \\> 30 mg\u002FdL, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1,000 mg per 24 hours or spot urine protein (mg\u002FdL) to creatinine (mg\u002FdL) ratio must be \\\u003C1.0.\n\n12\\. Left ventricular ejection fraction (LVEF) of \\> 50% by ECHO or MUGA within 56 days of enrollment. 13. Two readings of systolic blood pressure \\\u003C 140 mm Hg and diastolic blood pressure \\\u003C 90 mm Hg at screening taken at least 5 minutes apart in the sitting position after 5 minutes of rest. Subjects with well managed hypertension who are on oral antihypertensives must be on their current medication(s) and stable dose(s) for at least 2 weeks prior to enrollment.\n\nExclusion Criteria\n\n1. Prior treatment with or have known hypersensitivity to AL3818.\n2. a. Indication A - ASPS: Prior treatment with cediranib. b. Indication B - LMS: Prior treatment with or have known hypersensitivity to dacarbazine. (New Recruitment Suspended) c. Indication C - SS: Prior treatment with or have known hypersensitivity to dacarbazine.\n\n   d. Indication D - LMS: Prior treatment with anlotinib.\n3. Previous or concurrent cancer that is distinct in primary site or histology from ASPS, LMS, or SS within 5 years before enrollment except for successfully treated in situ carcinoma, non-melanoma skin cancer and superficial bladder tumors (Ta, Tis and T1).\n4. Received last dose of systemic cytotoxic therapy or investigational therapy within 21 days of enrollment or last dose of hormonal therapy, immunotherapy, targeted therapy or any other type of non-cytotoxic anti-cancer therapy within 14 days of enrollment.\n5. Prior treatment with extended-field radiotherapy (EFRT) within 28 days of enrollment or prior treatment with any other form of radiotherapy within 14 days of enrollment.\n6. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided that they are stable with no evidence of progression by imaging, and all neurologic symptoms have returned to baseline, and should not be using corticosteroids for at least 7 days prior to study treatment.\n7. Cavitary tumors or tumors invading or abutting large blood vessels in the thorax.\n8. History of gastrointestinal perforation, abdominal fistula or intra-abdominal abscess within 6 months of enrollment.\n9. Known history of bleeding disorders (e.g., von Willebrand disease or hemophilia).\n10. Clinically significant bleeding such as gross hematuria, gastrointestinal bleeding and hemoptysis within 6 months prior to enrollment.\n11. CTCAE version 4.03 \\> grade 2 pulmonary hemorrhage or \\> grade 3 of other forms of bleeding within 28 days prior to enrollment.\n12. History of untreated deep venous thrombosis (DVT) within the past 6 months. Patients with recent DVT who are treated with therapeutic anti-coagulating agents (excluding therapeutic warfarin which is exclusionary) for at least 14 days prior to start of study treatment.\n13. Use of aspirin (\\>325 mg\u002Fday) within 10 days prior to the first dose of study treatment.\n\n    The use of prophylactic therapeutic anti-coagulants are allowed provided that INR or aPTT are within therapeutic limits (according to the medical standard of the enrollment institution) and patient has been on a stable dose of anticoagulants for at least two weeks prior to the first dose of study treatment.\n14. Serious non-healing wound, active ulcer.\n15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment or minor surgical procedure within 7 days of enrollment.\n16. CTCAE version 4.03 \\> grade 3 peripheral neuropathy\n17. Any unrecovered toxicity reactions of CTCAE version 4.03 \\> grade 1 caused by any previous therapy (excluding alopecia and neurotoxicity \\\u003C grade 2)\n18. QTcF \\> 470 msec (per Fridericia's formula) on electrocardiogram within 28 days of enrollment.\n19. Severe and uncontrolled disease, including:\n\n    1. Class I and above myocardial ischemia or myocardial infarction, cardiac arrhythmia and Class 2 or above congestive heart failure classified according to New York Heart Association (NYHA)\n    2. Active or failed to control serious infections (CTCAE version 4.03 \\> grade 2 infections)\n    3. Liver disease such as cirrhosis of the liver, decompensated liver disease, chronic active hepatitis needing anti-viral therapy\n    4. Renal failure needing hemodialysis or peritoneal dialysis\n    5. Poorly controlled diabetes (HgA1C \\>8)\n    6. Untreated and uncontrolled epileptic seizures\n    7. History of psychotropic drug abuse and inability to quit\n    8. Untreated psychiatric disorders\n20. Known HIV-positive\n21. Had organ transplantation\n22. Clinical conditions affecting the intake and use of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction)\n23. Females who are pregnant or are breast-feeding.\n24. Concomitant treatment with strong inhibitors or inducers of CYP1A2, CYP3A4 or CYP3A5; or sensitive substrates with narrow therapeutic index (TI) of CYP3A4, CYP2C9 and CYP2C19; or QT prolongating medications within 14 days prior to enrollment and during the study unless there was an emergent or life-threatening medical condition that required it.\n25. Any medical intervention, condition or any other circumstance which in the opinion of the investigator or the sponsor's medical monitor, could compromise adherence to study procedures or study objectives.",{"count":345,"type":18},325,[194],"THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA.\n\nThis study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.",[349,22,350,351],"Alveolar Soft Part Sarcoma","Synovial Sarcoma","Soft-Tissue Sarcoma","2026-02-23",{"date":331,"type":31},{"date":355,"type":31},"2017-08-15",{"date":357,"type":18},"2028-12",{"name":359,"class":123},"Advenchen Laboratories, LLC",24,{"id":362,"slug":4,"hasResults":10,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":10,"sex":15,"minAge":368,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":69,"phases":371,"briefSummary":373,"conditions":374,"keywords":378,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100366742","NCT04055220","Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","A Multicentre Exploratory Phase II Study Describing the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","REGOSTA","INCLUSION CRITERIA :\n\nI1. Age ≥ 12 years at the day of consenting to the study;\n\nI2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas, Undifferentiated Pleomorphic Sarcomas (UPS), Leiomyosarcomas (LMS) and Angiosarcomas;\n\nI3. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed, consisting of a standard multimodal treatment based on the histological subtype:\n\nFor OS, (excepted head and neck localisations), neoadjuvant and\u002For adjuvant chemotherapy should include methotrexate-based regimen for patients \\\u003C 18 years old; patients ≥ 18 years old may have received either methotrexate-based regimen or anthracycline and cisplatin-based regimen For head and neck OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin, cisplatin or ifosfamide-based regimen.\n\nFor non-OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin and\u002For cisplatin-based regimen.\n\nI4. Recovery to NCI-CTCAE v5 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug\u002Fprocedure related toxicity (except alopecia, anaemia, and hypothyroidism);\n\nI5. Interval between the last chemotherapy administration and the date of randomisation: at least 4 weeks but no longer than 2 months;\n\nI6. Confirmed complete remission or no evidence of disease (for metastatic disease);\n\nPatients with pulmonary micro nodules can be included provided they do not meet the following criteria:\n\n* At least one lung nodule of 10mm or more\n* And\u002For at least two nodules well limited between 6-9mm\n* And\u002For at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic disease confirmed during the lung surgery of the residual lung lesions after pre-operative chemotherapy. If no other metastatic localisation is detected at the initial staging, the patient will be considered as localised disease and eligible for randomisation.\n\nI7. Life expectancy of greater than 12 months;\n\nI8. Karnofsky Performance status ≥70 (patients younger than 18-year old) or ECOG performance status \\\u003C 2 (adult patients) ;\n\nI9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:\n\n* Absolute neutrophil count ≥ 1.5 Giga\u002Fl\n* Platelets ≥ 100 Giga\u002Fl\n* Haemoglobin≥ 9 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN\n* Glomerular filtration rate (GFR) ≥30 ml\u002Fmin\u002F1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula\n* AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)\n* Bilirubin ≤1.5 X ULN\n* Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase \\> 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and\u002For GGT \\\u003C 1.5 x ULN.\n* Lipase ≤1.5 x ULN\n* Spot urine must not show ≥ 1 \"+\"protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1 \"+\" protein or more, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1000 mg\u002F24 hours\n\nI10. INR\u002FPTT ≤1.5 x ULN; Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR\u002FPTT is stable based on a measurement that is pre-dose as defined by the local standard of care;\n\nI11. Women of childbearing potential and male patients must agree to use adequate contraception (Appendix 4) for the duration of treatment and for 7 months (210 days) in WOCBP or 4 months (120 days) in men sexually active with WOCBP after the last dose of regorafenib;\n\nI12. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomization and\u002For urine pregnancy test within 48 hours before the first administration of the study treatment;\n\nI13. Patients, and their parents when applicable, must sign and date an informed consent document indicating that they have been informed of all the pertinent aspects of the trial prior to enrolment;\n\nI14. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;\n\nI15. Patients covered by a medical insurance.\n\nI16. Body Surface Area (BSA) ≥ 1.30m² at the time of consenting to the study.\n\nNON-INCLUSION CRITERIA :\n\nE1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor);\n\nE2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcomas and Ewing soft tissue sarcomas) and chordomas;\n\nE3. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization;\n\nE4. Cardiovascular dysfunction:\n\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%,\n* Congestive heart failure ≥ New York Heart Association (NYHA) class 2,\n* Myocardial infarction \\\u003C 6 months prior to first study drug administration,\n* Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),\n* Unstable (angina symptoms at rest) or new-onset angina within the last 3 months prior to first study drug administration;\n\nE5. Uncontrolled hypertension (systolic blood pressure \\> 150mmHg or diastolic pressure \\> 90 mmHg despite optimal treatment);\n\nE6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration;\n\nE7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration;\n\nE8. Ongoing infection \\> Grade 2 according to NCI-CTCAE v5;\n\nE9. Known history of human immunodeficiency virus (HIV) infection;\n\nNota Bene: Subjects with diagnosed human immunodeficiency virus (HIV) are eligible to participate in the study if they meet the following criteria:\n\n1. No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months prior to enrolment;\n2. No history of AIDS-defining cancers (e.g. Kaposi's sarcoma, aggressive B-cell lymphoma and invasive cervical cancer);\n3. Subjects should be on established anti-retroviral therapy for at least 4 weeks and have an HIV viral load of \\\u003C 400 copies\u002FmL prior to enrolment;\n\nE10. Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy; Nota Bene: Subjects with a history of hepatitis B or C who have normal alanine aminotransferase (ALT) and are hepatitis B surface antigen negative and\u002For have undetectable HCV RNA are eligible;\n\nE11. Dehydration according to NCI-CTC v5 Grade \\>1;\n\nE12. Difficulties to swallow oral medication and\u002For any mal-absorption condition and\u002For any Gastrointestinal (GI) disease that may significantly alter the absorption of regorafenib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection);\n\nE13. Patients with seizure disorder requiring medication;\n\nE14. Concurrent enrolment in another clinical trial in which investigational therapies are administered;\n\nE15. Known hypersensitivity to the active substance or to any of the excipients;\n\nE16. Pregnant women, women who are likely to become pregnant or are breast-feeding\n\nE17. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;\n\nE18. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;\n\nE19. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent;\n\nE20. Non-healing wound, non-healing ulcer, or non-healing bone fracture;\n\nE21. Patients with evidence or history of any bleeding diathesis, irrespective of severity;\n\nE22. Any haemorrhage or bleeding event ≥ CTCAE v5 Grade 3 within 4 weeks prior to the first study drug administration;\n\nE23. Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results;\n\nE24. Patients using prohibited concomitant and\u002For concurrent medications (see section \"Prohibited concomitant\u002Fconcurrent treatments);\n\nE25.Patients under tutorship or curatorship.","12 Years",{"count":370,"type":18},168,[372],"NA","Randomized, non-comparative, multicentre exploratory phase II study.\n\nTwo arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care). Regardless of their study arm, all the patients will be followed up until end of the study.\n\nThe comparison between these two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.",[375,142,144,376,377,22,252],"Bone Sarcoma","Chondrosarcoma","Undifferentiated Pleomorphic Sarcoma",[379,380,381,382,383,384,385,386,387,388,389,390,142,391,392,393,394,395],"Maintenance therapy","First line therapy","Regorafenib","Randomization","Double-blinded","Placebo controlled","Relapse-free survival","Time to treatment failure","Overall survival","Quality of life","Compliance","Bone sarcoma","Efficacy","Complete response","Tyrosine kinase inhibitor","Multi-target inhibitor","Safety","2026-02-13",{"date":398,"type":31},"2026-02-17",{"date":400,"type":31},"2020-03-03",{"date":402,"type":18},"2026-10-01",{"name":404,"class":38},"Centre Leon Berard",16,{"id":407,"slug":4,"hasResults":10,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":69,"phases":415,"briefSummary":416,"conditions":417,"keywords":423,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100605961","NCT07169344","Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma","PROSARC-1. Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-1","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.\n3. Primary tumor localized in head, neck, extremity, girdle and\u002For trunk wall.\n4. Measurable disease according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for PBT.\n\nExclusion Criteria:\n\n1. Locoregional or distant metastasis as assessed by CT and\u002For MRI at time of diagnosis. Patients with lung nodules \\\u003C10 mm of uncertain etiology may be included.\n2. Prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n3. Previous radiotherapy to the primary tumor region.\n4. Patients with pacemakers and\u002For implanted defibrillators.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.\n6. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.",{"count":414,"type":18},110,[169],"The purpose of the study is to investigate whether a personalized selection of patients with localized soft tissue sarcoma for preoperative proton radiation therapy can reduce long-term radiation side effects without increasing surgical complications or reducing the effectiveness of the treatment. Two radiation plans will be created for each patient-one for protons and one for photons-and through a national meeting, we will determine which type of radiation therapy each patient will receive. The radiation dose will be the same for both photons and protons.\n\nThe primary endpoint is surgical complications 120 days after surgery. Secondary endpoints include overall survival, local recurrence-free survival, disease-free survival, side effects, and quality of life. Furthermore, the study will investigate biomarkers that may predict response to radiation therapy, including changes in the tumor's genetic material (DNA), measurement of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe study will be conducted in Norway, with a planned inclusion of 110 patients.",[418,419,420,421,22,109,106,198,422],"Soft Tissue Sarcoma (Excluding GIST)","Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma of the Trunk and Extremities","Synovial Sarcomas","Pleomorphic Rhabdomyosarcoma",[424,425,426,427],"Soft tissue sarcoma","proton radiotherapy","x-ray radiotherapy","surgical complications","2026-01-26",{"date":430,"type":31},"2026-01-28",{"date":428,"type":31},{"date":433,"type":18},"2035-11-01",{"name":435,"class":38},"Oslo University Hospital",4,{"id":438,"slug":4,"hasResults":10,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":69,"phases":447,"briefSummary":448,"conditions":449,"keywords":454,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":87},"100581413","NCT06849986","IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)","Tislelizumab Combined With Liposomal Doxorubicin and Ifosfamide as First-line Treatment for Patients With Specified Subtypes of Unresectable or Metastatic Soft Tissue Sarcoma: a Multi-center, Single-arm, Prospective Phase II Clinical Trial","TAIS","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of gender;\n* Patients with histopathologically confirmed undifferentiated sarcoma (except small round cell undifferentiated sarcoma), synovial sarcoma, angiosarcoma, fibrosarcoma, smooth muscle sarcoma, liposarcoma (except well differentiated liposarcoma), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath meningiomas, desmoplastic small round cell tumor, not other specified (NOS), SMARCA4-deficient sarcoma, malignant phyllodes tumor of the breast, intimal sarcoma.\n* Patients with locally advanced disease that is not amenable to surgery\u002Fradiation therapy or with recurrent\u002Fmetastatic disease;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1;\n* Expected survival of more than 3 months;\n* Within 7 days prior to screening (including day 7), laboratory test data requirements: neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥90×10⁹\u002FL, hemoglobin ≥90g\u002FL (no blood transfusion within 14 days), serum total bilirubin ≤1.5 times the upper limit of normal (ULN); ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastases); serum creatinine ≤1.5× ULN or creatinine clearance rate ≥50ml\u002Fmin;\n* Presence of measurable lesions according to RECIST 1.1 criteria;\n* The subject (or their legal representative\u002Fguardian) must sign an informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate in this study.\n\nExclusion Criteria:\n\nAny of the following conditions will result in exclusion from the study:\n\n* Previous treatment for advanced soft tissue sarcoma, except for those who relapsed more than six months after adjuvant therapy with a cumulative dose of doxorubicin ≤300mg\u002Fm2;\n* Received any experimental or anti - tumor drugs within 4 weeks prior to enrollment;\n* Previously received any anti - PD - 1, anti - PD - L1, anti - PD - L2, anti - CD137, or anti - CTLA - 4 antibody treatment, or any other antibodies or drugs specifically targeting T - cell co - stimulation or checkpoint pathways;\n* History of other tumors within the past five years, except for cured cervical cancer or skin basal cell carcinoma; for patients with post - radiation sarcoma, another primary tumor must have no recurrence or metastasis;\n* Symptomatic brain or meningeal metastasis (unless the patient has been treated for more than 6 months, with negative imaging results within 4 weeks prior to enrollment, and stable tumor - related clinical symptoms at the time of enrollment);\n* Clinically significant active bleeding;\n* Pregnant or lactating women; women of childbearing potential who have not taken adequate contraceptive measures;\n* Alcohol abuse or drug addiction;\n* Patients with active autoimmune diseases or a history of such diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as patients who have undergone organ transplantation and require immunosuppressive therapy). Autoimmune hypothyroidism requiring only hormone replacement therapy or skin diseases not requiring systemic treatment are excluded;\n* Patients who need to receive systemic corticosteroids (equivalent to \\>10mg prednisone\u002Fday) within 14 days prior to enrollment or during the study, or those who require other immunosuppressive drug treatment. The use of topical or inhaled corticosteroids, or short - term (≤7 days) use of corticosteroids for prevention or treatment of non - autoimmune, non - frequent allergic diseases is excluded;\n* Failure of important organs or other severe diseases, including interstitial pneumonia, clinically significant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment;\n* History of human immunodeficiency virus infection, or other acquired or congenital immune deficiency diseases, or history of organ transplantation or stem cell transplantation;\n* Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, those with stable hepatitis B after drug treatment (DNA titer ≤10\\^3 copies\u002Fml), and those with cured hepatitis C (HCV RNA negative) are eligible for enrollment;\n* Severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation, or other concomitant diseases that, in the opinion of the investigator, seriously endanger the safety of the patient or affect the patient's ability to complete the study.","75 Years",{"count":446,"type":18},45,[169],"This study will enroll patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, and will combine tislelizumab with the standard chemotherapy of liposomal doxorubicin and ifosfamide to initially explore the efficacy and safety.",[450,252,267,22,451,452,453],"Soft Tissue Sarcomas","Pleomorphic Liposarcoma","Malignant Peripheral Nerve Sheath Tumor (MPNST)","Desmoplastic Small Round Cell Tumor",[455,456,457,458],"soft tissue sarcoma","tislelizumab","doxorubicin","ifosfamide","2026-01-07",{"date":461,"type":31},"2026-01-08",{"date":463,"type":31},"2025-02-25",{"date":465,"type":18},"2029-12-31",{"name":467,"class":38},"Fudan University",{"id":469,"slug":4,"hasResults":10,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":69,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":87},"100556719","NCT06528769","Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma","A Phase II Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed metastatic or locally advanced - unresectable Leiomyosarcoma (LMS)\n* Measurable disease based on RECIST 1.1. (At least one target lesion)\n* Patients must have received standard of care chemotherapy. No limits to prior lines of therapy.\n* Prior PD-1 and\u002For PD-L1 directed therapies are permitted. Minimal wash out period of 3 weeks for Pembrolizumab, Nivolumab , Durvalumab, 4 weeks for Ipilimumab.\n* ECOG performance status of 0-2.\n* Adequate organ function, as defined below.\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 \u002FmcL, hemoglobin ≥9 g\u002FdL (patients may be transfused to meet this criterion), lymphocytes ≥ 500\u002FmcL, platelets ≥ 100,000\u002FmcL\n  * Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or measured or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin for patients with creatinine levels \\> 1.5 X ULN (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or CrCl)\n  * Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 X ULN. FOr patients with known Gilbert disease, serum bilirubin ≤ 3 X ULN\n  * Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 X ULN or ≤ 5 X ULN for patients with liver metastases\n  * albumin ≥ 2.5 g\u002FdL\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless patients is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless the patients is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Anticipated life expectancy of ≥ 6 months.\n* Willing to comply with study procedures\n* Female patients of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Be willing and able to understand and sign the written informed consent document.\n* Ability to swallow and retain oral medication.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing not indicated for patients without known history of HIV.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Testing not indicated for patients without known history of HBV.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Testing not indicated for patients without known history of HCV.\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are stable on thyroid-replacement hormone are eligible for the study\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover ≤ 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses \\> 10 mg prednisone or equivalent or other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.\n* Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring increasing dosage of diuretics or paracentesis.\n* Has symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with asymptomatic CNS lesions will be eligible if considered appropriate by the treating physician. Patients with previously treated brain metastases may participate provided they have had a stable neurological status for at least 2 weeks after completion of definitive therapy. Patients may be on corticosteroids (≤ 10 mg of prednisone-equivalent) to control brain metastases if they have been on a stable dose for 2 weeks (14 days) prior to the start of study treatment and are clinically asymptomatic. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Pregnancy or breastfeeding or intention of becoming pregnant during study treatment or within 180 days for Cemiplimab after the final dose of study treatment\n\n  * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.\n  * Highly effective contraception should be used in women of childbearing potential during treatment with Cemiplimab and for at least 6 months following the last dose of Cemiplimab.\n* Any patient who has experienced unacceptable toxicity on prior checkpoint inhibitor therapy as detailed below:\n\n  1. ≥ Grade 3 AE related to checkpoint inhibitor.\n  2. Ongoing ≥ Grade 2 immune-related AE associated with checkpoint inhibitor with the exception of endocrine toxicities as detailed below.\n  3. CNS, ocular or cardiac AE of any grade related to checkpoint inhibitor. \\* NOTE: Patients with a prior or ongoing endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n* History of migraines requiring treatment within 3 months of study entry.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n\n  * History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 6 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 8 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Live, attenuated vaccines (e.g., FluMist®) are prohibited within 4 weeks prior to initiation of study treatment, during treatment with Cemiplimab, and for 5 months after the last dose of Cemiplimab.\n* Current treatment with anti-viral therapy for HBV\n* Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1\n* History of severe allergic anaphylactic reactions to human antibodies.\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the Cemiplimab formulation\n* Known allergy or hypersensitivity to any component of ATRA\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.",{"count":405,"type":18},[169],"A phase 2 study assessing the efficacy of all-trans retinoic acid (ATRA) and Cemiplimab in patients with metastatic\u002Flocally advanced - unresectable leiomyosarcoma (LMS) who have progressed standard-of-care therapy. Patients will be enrolled in cohorts according to a Bayesian Optimal Phase II design (BOP2).\n\nStudy treatment will consist of ATRA at a starting dose of 150 mg\u002Fm2\u002Fday for 3 days orally prior to each cycle of Cemiplimab 350 mg IV q3 weeks for three cycles and then Cemiplimab monotherapy until the progress of disease or unacceptable toxicities develops.",[22,101],"2025-09-24",{"date":480,"type":31},"2025-09-30",{"date":482,"type":31},"2025-09-10",{"date":484,"type":18},"2027-12-31",{"name":486,"class":38},"Gabriel Tinoco",{"id":488,"slug":4,"hasResults":10,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":69,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":87},"100537386","NCT06277154","MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age≥18 years and≤70 years;\n2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.\n3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.\n4. At least one measurable and assessable lesion defined by RECIST 1.1;\n5. ECOG performance status of 0-1;\n6. Estimated life expectancy≥6 months;\n7. Pulmonary function is basically normal;\n8. Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g\u002FL; b) Leukocyte≥3.5x10\\^9\u002FL; c) The absolute neutrophil count (ANC)\\>1.5x10\\^9\u002FL; d) Platelet≥100x10\\^9\u002FL; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \\[mainly unconjugated bilirubin\\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g\u002FL; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);\n9. Obtain the written informed consent of the patient\u002Flegal representative;\n10. Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.\n\nExclusion Criteria:\n\n1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.\n2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma\u002Fhemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.\n3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg\u002Fm2 doxorubicin.\n4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.\n5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg\u002Fday prednisone or its equivalent) and were still using them within 2 weeks before randomization.\n6. Use of immunomodulators and were still using them within 2 weeks before randomization.\n7. Allergic to sodium citrate or human albumin.\n8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.\n9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg\u002Fday prednisone or its equivalent).\n10. Have any active autoimmune disease or history of autoimmune disease.\n11. Subjects with active tuberculosis.\n12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.\n13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT\u002FQTc interval at baseline (male\\>450ms, female \\>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150\u002F95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.\n14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;\n15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;\n16. Known history of organ transplantation or ready to receive an organ transplantation;\n17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;\n18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.\n19. Surgery for soft tissue sarcoma is planned during the study.\n20. Subjects have participated in another investigational trial within 4 weeks before randomization.\n21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.","70 Years",{"count":495,"type":18},148,[169],"This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.",[22,198,350,252,377,499,500,267,422,501,453],"Epithelioid Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Endometrial Stromal Sarcoma","2025-07-20",{"date":504,"type":31},"2025-07-24",{"date":506,"type":31},"2024-02-21",{"date":508,"type":18},"2027-02",{"name":510,"class":123},"HRYZ Biotech Co.",{"id":512,"slug":4,"hasResults":10,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":517,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":518,"targetDuration":520,"studyType":19,"phases":4,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":87},"100583390","NCT06875700","Beliefs, Attitudes, and Response to Genetic Testing in SarcomaPatients","Beliefs, Attitudes, and Response to Genetic Testing in Sarcoma Patients","Inclusion LMS Proband\n\n* Actionable germline PV detected in the research context\n* Living\n* No prior germline testing for this PV\n* Able to speak and read English\n* Mentally competent\n* Age 18 or older\n\nRelative of LMS Proband\n\n* 25-50% chance for having inherited the PV\n* No prior germline testing for this PV\n* Able to speak and read English\n* Mentally competent\n* Age 18 or older\n\nExclusion (both cohorts)\n\n* \\\u003C18 years\n* Unable to read or write",true,{"count":519,"type":18},300,"3 Months","Genomic research has shown that a portion of leiomyosarcomas can be attributed to an underlying cancer predisposition syndrome. However, the optimal approach for incorporating germline testing into the care of these patients. This study is assessing the beliefs about the heritability of leiomyosarcoma and other cancer risks, and attitudes towards germline testing among leiomyosarcoma patients.",[22],"2025-06-11",{"date":525,"type":31},"2025-06-13",{"date":527,"type":31},"2024-07-09",{"date":529,"type":18},"2027-08",{"name":531,"class":38},"University of Utah",{"id":533,"slug":4,"hasResults":10,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":539,"targetDuration":541,"studyType":19,"phases":4,"briefSummary":542,"conditions":543,"keywords":886,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":929,"lastUpdatePostDateStruct":930,"startDateStruct":932,"completionDateStruct":934,"leadSponsor":936,"locationsCount":938},"100193378","NCT01793168","Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford","Coordination of Rare Diseases at Sanford","CoRDS","Inclusion Criteria:\n\n* Diagnosis of a rare disease, a disease of unknown prevalence, undiagnosed or an unaffected carrier of a rare\u002Funcommon disease\n\nExclusion Criteria:\n\n* Diagnosis of a disease which is not rare",{"count":540,"type":18},20000,"100 Years","CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org\u002FCoRDS to enroll.",[544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,22,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683,684,685,686,687,688,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716,717,718,719,720,721,722,723,724,725,726,727,728,729,730,731,732,733,734,735,736,737,738,739,740,741,742,743,744,745,746,747,748,749,750,751,752,753,754,755,756,757,758,759,760,761,762,763,764,765,766,767,768,769,770,771,772,773,774,775,776,777,778,779,780,781,782,783,784,785,786,787,788,789,790,791,792,793,794,795,796,797,798,799,800,801,802,803,804,805,806,807,808,809,810,811,812,813,814,815,816,817,818,819,820,821,822,823,824,825,826,827,828,829,830,831,832,833,834,835,836,837,838,839,840,841,842,843,844,845,846,847,848,849,850,851,852,853,854,855,856,857,858,859,860,861,862,863,864,865,866,867,868,869,870,871,872,873,874,875,876,877,878,879,880,881,882,883,884,885],"Rare Disorders","Undiagnosed Disorders","Disorders of Unknown Prevalence","Cornelia De Lange Syndrome","Prenatal Benign Hypophosphatasia","Perinatal Lethal Hypophosphatasia","Odontohypophosphatasia","Adult Hypophosphatasia","Childhood-onset Hypophosphatasia","Infantile Hypophosphatasia","Hypophosphatasia","Kabuki Syndrome","Bohring-Opitz Syndrome","Narcolepsy Without Cataplexy","Narcolepsy-cataplexy","Hypersomnolence Disorder","Idiopathic Hypersomnia Without Long Sleep Time","Idiopathic Hypersomnia With Long Sleep Time","Idiopathic Hypersomnia","Kleine-Levin Syndrome","Kawasaki Disease","Leiomyosarcoma of the Corpus Uteri","Leiomyosarcoma of the Cervix Uteri","Leiomyosarcoma of Small Intestine","Acquired Myasthenia Gravis","Addison Disease","Hyperacusis (Hyperacousis)","Juvenile Myasthenia Gravis","Transient Neonatal Myasthenia Gravis","Williams Syndrome","Lyme Disease","Myasthenia Gravis","Marinesco Sjogren Syndrome(Marinesco-Sjogren Syndrome)","Isolated Klippel-Feil Syndrome","Frasier Syndrome","Denys-Drash Syndrome","Beckwith-Wiedemann Syndrome","Emanuel Syndrome","Isolated Aniridia","Axenfeld-Rieger Syndrome","Aniridia-intellectual Disability Syndrome","Aniridia - Renal Agenesis - Psychomotor Retardation","Aniridia - Ptosis - Intellectual Disability - Familial Obesity","Aniridia - Cerebellar Ataxia - Intellectual Disability","Aniridia - Absent Patella","Aniridia","Peters Anomaly - Cataract","Peters Anomaly","Potocki-Shaffer Syndrome","Silver-Russell Syndrome Due to Maternal Uniparental Disomy of Chromosome 11","Silver-Russell Syndrome Due to Imprinting Defect of 11p15","Silver-Russell Syndrome Due to 11p15 Microduplication","Syndromic Aniridia","WAGR Syndrome","Wolf-Hirschhorn Syndrome","4p16.3 Microduplication Syndrome","4p Deletion Syndrome, Non-Wolf-Hirschhorn Syndrome","Autosomal Recessive Stickler Syndrome","Stickler Syndrome Type 2","Stickler Syndrome Type 1","Stickler Syndrome","Mucolipidosis Type 4","X-linked Spinocerebellar Ataxia Type 4","X-linked Spinocerebellar Ataxia Type 3","X-linked Intellectual Disability - Ataxia - Apraxia","X-linked Progressive Cerebellar Ataxia","X-linked Non Progressive Cerebellar Ataxia","X-linked Cerebellar Ataxia","Vitamin B12 Deficiency Ataxia","Toxic Exposure Ataxia","Unclassified Autosomal Dominant Spinocerebellar Ataxia","Thyroid Antibody Ataxia","Sporadic Adult-onset Ataxia of Unknown Etiology","Spinocerebellar Ataxia With Oculomotor Anomaly","Spinocerebellar Ataxia With Epilepsy","Spinocerebellar Ataxia With Axonal Neuropathy Type 2","Spinocerebellar Ataxia Type 8","Spinocerebellar Ataxia Type 7","Spinocerebellar Ataxia Type 6","Spinocerebellar Ataxia Type 5","Spinocerebellar Ataxia Type 4","Spinocerebellar Ataxia Type 37","Spinocerebellar Ataxia Type 36","Spinocerebellar Ataxia Type 35","Spinocerebellar Ataxia Type 34","Spinocerebellar Ataxia Type 32","Spinocerebellar Ataxia Type 31","Spinocerebellar Ataxia Type 30","Spinocerebellar Ataxia Type 3","Spinocerebellar Ataxia Type 29","Spinocerebellar Ataxia Type 28","Spinocerebellar Ataxia Type 27","Spinocerebellar Ataxia Type 26","Spinocerebellar Ataxia Type 25","Spinocerebellar Ataxia Type 23","Spinocerebellar Ataxia Type 22","Spinocerebellar Ataxia Type 21","Spinocerebellar Ataxia Type 20","Spinocerebellar Ataxia Type 2","Spinocerebellar Ataxia Type 19\u002F22","Spinocerebellar Ataxia Type 18","Spinocerebellar Ataxia Type 17","Spinocerebellar Ataxia Type 16","Spinocerebellar Ataxia Type 15\u002F16","Spinocerebellar Ataxia Type 14","Spinocerebellar Ataxia Type 13","Spinocerebellar Ataxia Type 12","Spinocerebellar Ataxia Type 11","Spinocerebellar Ataxia Type 10","Spinocerebellar Ataxia Type 1 With Axonal Neuropathy","Spinocerebellar Ataxia Type 1","Spinocerebellar Ataxia - Unknown","Spinocerebellar Ataxia - Dysmorphism","Non Progressive Epilepsy and\u002For Ataxia With Myoclonus as a Major Feature","Spasticity-ataxia-gait Anomalies Syndrome","Spastic Ataxia With Congenital Miosis","Spastic Ataxia - Corneal Dystrophy","Spastic Ataxia","Rare Hereditary Ataxia","Rare Ataxia","Recessive Mitochondrial Ataxia Syndrome","Progressive Epilepsy and\u002For Ataxia With Myoclonus as a Major Feature","Posterior Column Ataxia - Retinitis Pigmentosa","Post-Stroke Ataxia","Post-Head Injury Ataxia","Post Vaccination Ataxia","Polyneuropathy - Hearing Loss - Ataxia - Retinitis Pigmentosa - Cataract","Muscular Atrophy - Ataxia - Retinitis Pigmentosa - Diabetes Mellitus","Non-hereditary Degenerative Ataxia","Paroxysmal Dystonic Choreathetosis With Episodic Ataxia and Spasticity","Olivopontocerebellar Atrophy - Deafness","NARP Syndrome","Myoclonus - Cerebellar Ataxia - Deafness","Multiple System Atrophy, Parkinsonian Type","Multiple System Atrophy, Cerebellar Type","Multiple System Atrophy","Maternally-inherited Leigh Syndrome","Machado-Joseph Disease Type 3","Machado-Joseph Disease Type 2","Machado-Joseph Disease Type 1","Leigh Syndrome","Late-onset Ataxia With Dementia","Infection or Post Infection Ataxia","GAD Ataxia","Hereditary Episodic Ataxia","Gliadin\u002FGluten Ataxia","Friedreich Ataxia","Fragile X-associated Tremor\u002FAtaxia Syndrome","Familial Paroxysmal Ataxia","Exposure to Medications Ataxia","Episodic Ataxia With Slurred Speech","Episodic Ataxia Unknown Type","Episodic Ataxia Type 7","Episodic Ataxia Type 6","Episodic Ataxia Type 5","Episodic Ataxia Type 4","Episodic Ataxia Type 3","Episodic Ataxia Type 1","Epilepsy and\u002For Ataxia With Myoclonus as Major Feature","Early-onset Spastic Ataxia-neuropathy Syndrome","Early-onset Progressive Neurodegeneration - Blindness - Ataxia - Spasticity","Early-onset Cerebellar Ataxia With Retained Tendon Reflexes","Early-onset Ataxia With Dementia","Childhood-onset Autosomal Recessive Slowly Progressive Spinocerebellar Ataxia","Dilated Cardiomyopathy With Ataxia","Cataract - Ataxia - Deafness","Cerebellar Ataxia, Cayman Type","Cerebellar Ataxia With Peripheral Neuropathy","Cerebellar Ataxia - Hypogonadism","Cerebellar Ataxia - Ectodermal Dysplasia","Cerebellar Ataxia - Areflexia - Pes Cavus - Optic Atrophy - Sensorineural Hearing Loss","Brain Tumor Ataxia","Brachydactyly - Nystagmus - Cerebellar Ataxia","Benign Paroxysmal Tonic Upgaze of Childhood With Ataxia","Autosomal Recessive Syndromic Cerebellar Ataxia","Autosomal Recessive Spastic Ataxia With Leukoencephalopathy","Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay","Autosomal Recessive Spastic Ataxia - Optic Atrophy - Dysarthria","Autosomal Recessive Spastic Ataxia","Autosomal Recessive Metabolic Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to Repeat Expansions That do Not Encode Polyglutamine","Autosomal Recessive Ataxia, Beauce Type","Autosomal Recessive Ataxia Due to Ubiquinone Deficiency","Autosomal Recessive Ataxia Due to PEX10 Deficiency","Autosomal Recessive Degenerative and Progressive Cerebellar Ataxia","Autosomal Recessive Congenital Cerebellar Ataxia Due to MGLUR1 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia Due to GRID2 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia","Autosomal Recessive Cerebellar Ataxia-pyramidal Signs-nystagmus-oculomotor Apraxia Syndrome","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to WWOX Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to TUD Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to KIAA0226 Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome","Autosomal Recessive Cerebellar Ataxia With Late-onset Spasticity","Autosomal Recessive Cerebellar Ataxia Due to STUB1 Deficiency","Autosomal Recessive Cerebellar Ataxia Due to a DNA Repair Defect","Autosomal Recessive Cerebellar Ataxia - Saccadic Intrusion","Autosomal Recessive Cerebellar Ataxia - Psychomotor Retardation","Autosomal Recessive Cerebellar Ataxia - Blindness - Deafness","Autosomal Recessive Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to a Polyglutamine Anomaly","Autosomal Dominant Spinocerebellar Ataxia Due to a Point Mutation","Autosomal Dominant Spinocerebellar Ataxia Due to a Channelopathy","Autosomal Dominant Spastic Ataxia Type 1","Autosomal Dominant Spastic Ataxia","Autosomal Dominant Optic Atrophy","Ataxia-telangiectasia Variant","Ataxia-telangiectasia","Autosomal Dominant Cerebellar Ataxia, Deafness and Narcolepsy","Autosomal Dominant Cerebellar Ataxia Type 4","Autosomal Dominant Cerebellar Ataxia Type 3","Autosomal Dominant Cerebellar Ataxia Type 2","Autosomal Dominant Cerebellar Ataxia Type 1","Autosomal Dominant Cerebellar Ataxia","Ataxia-telangiectasia-like Disorder","Ataxia With Vitamin E Deficiency","Ataxia With Dementia","Ataxia - Oculomotor Apraxia Type 1","Ataxia - Other","Ataxia - Genetic Diagnosis - Unknown","Acquired Ataxia","Adult-onset Autosomal Recessive Cerebellar Ataxia","Alcohol Related Ataxia","Multiple Endocrine Neoplasia","Multiple Endocrine Neoplasia Type II","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Multiple Endocrine Neoplasia, Type IV","Multiple Endocrine Neoplasia, Type 3","Multiple Endocrine Neoplasia (MEN) Syndrome","Multiple Endocrine Neoplasia Type 2B","Multiple Endocrine Neoplasia Type 2A","Atypical Hemolytic Uremic Syndrome","Atypical HUS","Wiedemann-Steiner Syndrome","Breast Implant-Associated Anaplastic Large Cell Lymphoma","Autoimmune\u002FInflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis","Behcet's Disease","Alagille Syndrome","Inclusion Body Myopathy With Early-onset Paget Disease and Frontotemporal Dementia (IBMPFD)","Lowe Syndrome","Pitt Hopkins Syndrome","1p36 Deletion Syndrome","Jansen Type Metaphyseal Chondrodysplasia","Cockayne Syndrome","Chronic Recurrent Multifocal Osteomyelitis","CRMO","Malan Syndrome","Hereditary Sensory and Autonomic Neuropathy Type Ie","VCP Disease","Hypnic Jerking","Sleep Myoclonus","Mollaret Meningitis","Recurrent Viral Meningitis","CRB1","Leber Congenital Amaurosis","Retinitis Pigmentosa","Rare Retinal Disorder","KCNMA1-Channelopathy","Primary Biliary Cirrhosis","ZMYND11","Transient Global Amnesia","Glycogen Storage Disease","Alstrom Syndrome","White Sutton Syndrome","DNM1","EIEE31","Myhre Syndrome","Recurrent Respiratory Papillomatosis","Laryngeal Papillomatosis","Tracheal Papillomatosis","Refsum Disease","Nicolaides Baraitser Syndrome","Leukodystrophy","Tango2","Cauda Equina Syndrome","Rare Gastrointestinal Disorders","Achalasia-Addisonian Syndrome","Achalasia Cardia","Achalasia Icrocephaly Syndrome","Anal Fistula","Congenital Sucrase-Isomaltase Deficiency","Eosinophilic Gastroenteritis","Idiopathic Gastroparesis","Hirschsprung Disease","Rare Inflammatory Bowel Disease","Intestinal Pseudo-Obstruction","Scleroderma","Short Bowel Syndrome","Sacral Agenesis","Sacral Agenesis Syndrome","Caudal Regression","Scheuermann Disease","SMC1A Truncated Mutations (Causing Loss of Gene Function)","Cystinosis","Juvenile Nephropathic Cystinosis","Nephropathic Cystinosis","Kennedy Disease","Spinal Bulbar Muscular Atrophy","Warburg Micro Syndrome","Mucolipidoses","Mitochondrial Diseases","Mitochondrial Aminoacyl-tRNA Synthetases","Mt-aaRS Disorders","Hypertrophic Olivary Degeneration","Non-Ketotic Hyperglycinemia","Fish Odor Syndrome","Halitosis","Isolated Congenital Asplenia","Lambert Eaton (LEMS)","Biliary Atresia","STAG1 Gene Mutation","Coffin Lowry Syndrome","Borjeson-Forssman-Lehman Syndrome","Blau Syndrome","Arginase 1 Deficiency","HSPB8 Myopathy","Beta-Mannosidosis","TBX4 Syndrome","DHDDS Gene Mutations","MAND-MBD5-Associated Neurodevelopmental Disorder","Constitutional Mismatch Repair Deficiency (CMMRD)","SPATA5 Disorder","SPATA5L1 Related Disorder","Acrodysostosis","Multi-systematic Smooth Muscle Dysfunction Syndrome","CRELD1 (Cysteine Rich With EGF Like Domains 1)","GNB1 Syndrome","Pyruvate Dehydrogenase Complex Deficiency Disease","Beta Mannosidosis","Kbg Syndrome","Labrune Syndrome","Metachromatic Leukodystrophy (MLD)","Moyamoya Disease","OPHN1 Syndrome","Oculopharyngeal Muscular Dystrophy (OPMD)","TUBB3 Mutation","WOREE (WWOX-related Epileptic Encephalopathy","SCAR12","Skraban-Deardorff Syndrome","Hereditary Myopathy With Early Respiratory Failure",[887,888,889,890,891,597,892,893,604,894,564,895,896,897,767,776,898,899,555,900,901,563,902,22,903,554,904,905,779,906,907,782,783,908,785,786,909,910,789,911,912,913,839,914,915,916,917,918,919,920,844,921,922,923,849,850,924,925,926,927,928],"Rare Diseases","Neglected Diseases","Orphan Diseases","Rare Disease Research","Registries","Ataxia","Cornelia de Lange Syndrome","Ataxia Telangiectasia","Batten Disease","Mucolipidosis IV","Klippel-Feil Syndrome","Undiagnosed","Uncommon Disease","Hypersomnia","Hyperacusis","Marinesco-Sjogren Syndrome","4p-\u002FWolf-Hirschhorn Syndrome","Narcolepsy","Wiedermann-Steiner Syndrome","Autoimmune\u002Finflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis (HLH)","Inclusion body myopathy with early-onset Paget disease and frontotemporal dementia (IBMPFD)","1p36 deletion syndrome","Jansen metaphyseal chondrodysplasia","Chronic recurrent multifocal osteomyelitis (CRMO)","Malan syndrome","Hereditary Sensory and Autonomic Neuropathy","Juvenile nephropathic cystinosis","Nephropathic infantile cystinosis","Ocular cystinosis","Kennedy disease","Spinal Bulbar Muscular Atrophy (SBMA)","SMC1A Truncated Mutations (causing loss of gene function)","Leigh syndrome","Mucolipidosis","Mitochondrial aminoacyl-tRNA synthetases (Mt-aaRS Disorders)","Shine Syndrome","Intestinal Bromhidrosis Syndrome","Fish odor syndrome","Autosomal recessive extra oral halitosis","CACNA1H mutation","Dimethylglycine dehydrogenase deficiency","2025-05-22",{"date":931,"type":31},"2025-05-29",{"date":933,"type":31},"2010-07",{"date":935,"type":18},"2100-12",{"name":937,"class":38},"Sanford Health",2,{"id":940,"slug":4,"hasResults":10,"nctId":941,"briefTitle":942,"officialTitle":943,"acronym":944,"eligibilityCriteria":945,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":946,"targetDuration":4,"studyType":69,"phases":948,"briefSummary":949,"conditions":950,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":951,"lastUpdatePostDateStruct":952,"startDateStruct":954,"completionDateStruct":956,"leadSponsor":958,"locationsCount":87},"100403588","NCT04535271","Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma","TAGGED: A Phase 2 Study Using Low Dose\u002FMetronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd\u002F3rd\u002F4th Line Therapy for Advanced Soft Tissue Sarcoma","TAGGED","Inclusion Criteria:\n\n* Male or Female ≥ 18 years of age\n* Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma\n* Previously treated patient with measurable disease by RECIST v1.1\n* ECOG performance status ≤ 2\n* Life expectancy of at least 3 months\n* Acceptable liver function: Bilirubin \\\u003C 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \\\u003C 2.5 x ULN (\\\u003C 5 x ULN if liver metastases present)\n* Acceptable renal function: Creatinine \\\u003C 1.5 times ULN and creatinine clearance \\> 60 ml\u002Fmin using the Crockroft-Gault formula\n* Acceptable hematologic status: ANC \\>1000 cells\u002FμL; Platelet count \\>100,000\u002FμL; Hemoglobin \\> 9.0 g\u002FdL\n* INR and PT \\\u003C 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants\n* Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB\u002FEthics Committee\n* Willingness to comply with all study procedures and availability for the duration of the study\n* All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\n* Currently receiving treatment with another investigational device or drug study, or \\\u003C14 days since ending treatment with another investigational device or drug study(s).\n* Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.\n* Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.\n* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.\n* Sexually active subjects and their partners unwilling to use male or female latex condom",{"count":947,"type":18},80,[169],"This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.",[22],"2025-02-21",{"date":953,"type":31},"2025-02-24",{"date":955,"type":31},"2021-09-09",{"date":957,"type":18},"2029-03-30",{"name":959,"class":38},"Sarcoma Oncology Research Center, LLC",{"id":961,"slug":4,"hasResults":10,"nctId":962,"briefTitle":963,"officialTitle":964,"acronym":4,"eligibilityCriteria":965,"healthyVolunteers":10,"sex":15,"minAge":966,"maxAge":967,"enrollmentInfo":968,"targetDuration":4,"studyType":69,"phases":970,"briefSummary":971,"conditions":972,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":985,"lastUpdatePostDateStruct":986,"startDateStruct":988,"completionDateStruct":990,"leadSponsor":992,"locationsCount":4},"100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":969,"type":18},1582,[372],"This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[973,974,975,349,252,976,108,977,978,267,979,22,980,981,451,982,101,143,420,983,984,350,377],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Clear Cell Sarcoma of Soft Tissue","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Malignant Peripheral Nerve Sheath Tumor","Myxofibrosarcoma","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","2024-07-24",{"date":987,"type":31},"2024-07-30",{"date":989,"type":18},"2025-01-28",{"date":991,"type":18},"2032-11-01",{"name":993,"class":208},"ECOG-ACRIN Cancer Research Group",{"id":995,"slug":4,"hasResults":10,"nctId":996,"briefTitle":997,"officialTitle":997,"acronym":998,"eligibilityCriteria":999,"healthyVolunteers":517,"sex":1000,"minAge":66,"maxAge":1001,"enrollmentInfo":1002,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":1003,"conditions":1004,"keywords":1005,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":1008,"lastUpdatePostDateStruct":1009,"startDateStruct":1011,"completionDateStruct":1013,"leadSponsor":1015,"locationsCount":87},"100556128","NCT06521060","The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions","MYSTR","Inclusion Criteria:\n\n* Signed informed consent\n* Age ≥ 18 years\n* Women indicated for uterus-preserving surgery (tumour resection) or hysterectomy for myometrial lesion ('myoma-like' uterine tumour(s))\n* USG finding of atypical myometrial lesion\u002Fs a\n\nExclusion Criteria:\n\npatient 's refusal\n\n* age \\\u003C 18 years\n* ongoing pregnancy\n* inability to perform TCB \u002Fcontraindications for TCB (trombocytopenia, coagulopathy, PID, colpitis) or definitive surgery (myomectomy or hysterectomy)\n* USG finding of more than 2 atypical lesion\u002Fs with a diameter ≤ 20 mm and ≥ 100 mm\n* inability to perform any of the 3 core needle biopsy approaches (transvervical, trans uterine cavity, transvaginal) because of anatomical, localization issues. The percutaneous transabdominal biopsy is not allowed\n* Polymyomatous uterus that may not be examined adequately with routine transvaginal ultrasound\n* myoma (which would be subject to TCB) type 7 according to FIGO classification 16\n* history of conservative hormonal therapy less than 3 months prior to study enrolment\n* history of conservative therapy via uterine artery embolisation or laparoscopic uterine artery occlusion\n* history of pregnancy less than one year prior to study enrollment","FEMALE","80 Years",{"count":192,"type":18},"The Tru-cut biopsy (TCB) for targeting pelvic tumors is well established in gynecologic oncology. However, its reliability for differentiating of uterine sarcoma in \"myoma-like\" uterine lesions has been confirmed by only a few studies, which were either retrospective or provided only pilot result on the limited number of prospectively enrolled patients (N=34). Proving that preoperative TCB can provide accurate information about the histological nature of the tumor would have great impact for setting an adequate tailored oncologically safe approach, especially in patients with sonographically atypical lesions. Additionally, the biopsy should be safe, with transcervical, transuterine cavity (\"in organ\" biopsy) approaches preferred to avoid the risk of needle canal contamination if sarcoma is diagnosed. The purpose of this study is to evaluate the accuracy of the Tru-cut biopsy (TCB) of sonographically atypical myometrial lesions as a complementary diagnostic method in the preoperative management of patients scheduled for uterus preserving procedure or hysterectomy. Additionally, we aim to assess the impact of this procedure on patients´ quality of life and clinical management. MYSTR is a single arm, prospective, multicentric cohort study.",[22],[1006,1007],"tru cut biopsy","leiomyoma","2024-07-22",{"date":1010,"type":31},"2024-07-25",{"date":1012,"type":18},"2024-10",{"date":1014,"type":18},"2028-06",{"name":1016,"class":38},"Charles University, Czech Republic",{"id":1018,"slug":4,"hasResults":10,"nctId":1019,"briefTitle":1020,"officialTitle":1021,"acronym":1022,"eligibilityCriteria":1023,"healthyVolunteers":10,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":1024,"targetDuration":4,"studyType":69,"phases":1026,"briefSummary":1027,"conditions":1028,"keywords":1031,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":1033,"lastUpdatePostDateStruct":1034,"startDateStruct":1036,"completionDateStruct":1038,"leadSponsor":1039,"locationsCount":1041},"100230260","NCT02275286","Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients","Phase I-II Prospective Trial, Multicenter, Open Label, Exploring the Combination of Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients","TRASTS","Cohort A: STS\n\nInclusion Criteria:\n\n1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n2. Aged equal or over 18.\n3. Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy.A centralized diagnostic will be performed, the tumor sample must be available and sent prior to inclusion.\n4. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n5. Metastatic spread could be present in two organs at maximum (i.e. lungs and pelvic fosa).\n6. Those lesions considered for radiation therapy have to be considered as target lesions as well. (i.e. in a patient with nodules in lungs, those lesions selected for radiation therapy have to include at least the target lesions)\n7. It is allowed that not all the lesions will be under radiation fields. As a general rule, it will be prioritized to select, as target-irradiating lesions, those with greater increase in size and those largest lesions. It should be discouraged to irradiate pulmonary lesions with infiltration of pleural serosa.\n8. Patients must have documentation of disease progression within 6 months prior to study entry.\n9. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced\u002Fmetastatic disease are allowed as long as trabectedin has not been included.\n10. The following histological subtypes can be included:\n\n    Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma) Leiomyosarcoma Angiosarcoma\u002F epithelial hemangioendothelioma Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid\u002Fround cells, pleomorphic).\n\n    Synovial sarcoma Fibrosarcoma and its variants (epithelial fibrosarcoma\u002Flow grade fibromyxoid sarcoma) Hemangiopericytoma\u002Fsolitary fibroid tumor Neurogenic sarcoma (Malignant peripheral nerve sheath tumor, MPNST) Myxofibrosarcoma Epithelioid Sarcoma Unclassified sarcoma (spindle cell\u002Fepithelioid\u002Fpleomorphic\u002Fmyxoid)\n11. Measurable disease, according to RECIST V 1.1 criteria\n12. Performance status ≤1 (ECOG).\n13. Adequate respiratory functions: FEV1 \\>1L; DLco \\> 40% (patients with pulmonary target lesions)\n14. Adequate bone marrow function (hemoglobin \\> 10 g\u002Fdl, leukocytes ≥ 3.000\u002Fmm3, neutrophils ≥ 1.500\u002Fmm3, platelets ≥ 100.000\u002Fmm3). Patients with plasma creatinine ≤ 1,6 mg\u002Fdl, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is \\> 2.5 times the UNL, then the alkaline phosphatase liver fraction and\u002For GGT must be ≤ UNL.\n15. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n16. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n17. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study)\n18. Patient must have a Central Venous Catheter for treatment\n\nExclusion Criteria:\n\n1. Previous treatment with trabectedin or previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissues constrains)\n2. Performance status ≥ 2 (ECOG).\n3. Plasma bilirubin \\> UNL.\n4. Creatinine \\> 1.6 mg\u002FdL.\n5. History of other neoplastic disease with less than 5 years free of disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n6. Severe COPD or other severe pulmonary diseases.\n7. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n8. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n9. Uncontrolled bacterial, mycotic or viral infections.\n10. Known positive test for infection by human immunodeficiency virus (HIV).\n11. Women who are pregnant or breast-feeding.\n12. Psychological, familial, social or geographic circumstances that limit the patient\"s ability to comply with the protocol or informed consent.\n13. Patients participating in another clinical trial or receiving any other investigational product\n14. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n15. Histologies other than those described in inclusion criteria.\n\nCohort B: ML\n\nInclusion criteria:\n\n1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n2. Age ≥18 years old.\n3. Pathological diagnosis of Myxoid Liposarcoma, deep located and more than 5 cm or superficial more than 10 cm. A centralized diagnostic will be performed to confirm that the patient can be included in the study.\n4. Tumor must be resectable and without evidence of regional or distal spread after adequate staging procedure. Tumor must be located in limbs or superficial trunk wall.\n5. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n6. Measurable disease, according to RECIST V 1.1 criteria\n7. Performance status 0-1 (ECOG).\n8. Adequate bone marrow function (hemoglobin \\> 10 g\u002FdL, leukocytes ≥ 3.000\u002Fmm3, neutrophils ≥ 1.500\u002Fmm3, platelets ≥ 100.000\u002Fmm3). Patients with plasma creatinine ≤ 1,6 mg\u002FdL, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is \\> 2.5 times the UNL, then the alkaline phosphatase liver fraction and\u002For GGT must be ≤ UNL.\n9. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n10. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n11. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA HBV+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).\n12. Patient may have had one previous chemotherapy line.\n13. Patient must have a Central Venous Catheter for treatment.\n\nExclusion criteria:\n\n1. Unresectable tumors (with limb sparing surgery)\n2. More than one previous chemotherapy treatment for local disease including trabectedin.\n3. Radiotherapy involving the tumoral bed.\n4. Performance status ≥ 2 (ECOG).\n5. Presence of metastases or lymph node involvement by the tumor.\n6. Location other than limb or superficial trunk wall.\n7. Plasma bilirubin \\> UNL.\n8. Creatinine \\> 1.6 mg\u002FdL.\n9. History of other neoplastic disease with less than 5 years free of disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n10. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n11. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n12. Uncontrolled bacterial, mycotic or viral infections.\n13. Known positive test for infection by human immunodeficiency virus (HIV).\n14. Women who are pregnant or breast-feeding.\n15. Psychological, familial, social or geographic circumstances that limit the patient\"s ability to comply with the protocol or informed consent.\n16. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n\nCohorts C and D: Retroperitoneum sarcoma\n\nInclusion criteria:\n\n1. The patient must voluntarily sign the informed consent form before performing any study-specific test that is not part of the patient's usual care.\n2. Aged between 18 and 75 years.\n3. The following histological subtypes may be included in the cohort C:\n\n   High grade leiomyosarcoma (G2-3), liposarcoma (G2-3), if at least 30% of the tumour is dedifferentiated, pleomorphic liposarcoma.\n\n   The following histological subtypes may be included in the cohort D:\n\n   Well differentiated liposarcoma (WD liposarcoma) and G2 dedifferentiated liposarcorcoma, if less than 30% of the tumour is dedifferentiated.\n\n   A centralised diagnosis will be made to confirm that the patient can be included in the study.\n4. The tumour must be located in the retroperitoneum and it must be resectable and without evidence of regional or distal spread after the appropriate staging process. This point must be confirmed by the central surgeon reviewer.\n5. The location and size of the disease in the retroperitoneum must allow for compliance with radiotherapy limitations in healthy tissue. This point must be confirmed by the site's radiation oncologist and the central radiation oncologist reviewer.\n6. Measurable disease according to CHOI criteria for cohort C and RECIST V 1.1 criteria for cohort D.\n7. ECOG performance status 0-1.\n8. Adequate haematological parameters (haemoglobin \\>10 g\u002Fdl, leukocytes ≥3,000\u002Fmm3, neutrophils ≥1,500\u002Fmm3, platelets ≥100,000\u002Fmm3). Patients with plasma creatinine ≤1.6 mg\u002Fdl, transaminases ≤2.5 times the ULN, total bilirubin ≤ ULN, CPK ≤2.5 times ULN, alkaline phosphatase ≤2.5 times ULN are acceptable. If the increase in alkaline phosphatase is \\>2.5 times the ULN, the liver fraction of alkaline phosphatase and\u002For GGT should be ≤ULN.\n9. Fertile men or women must use an effective contraceptive method before starting the study, during the study and for 6 months following the conclusion thereof. Women of childbearing potential who participate in the study must undergo a pregnancy test before starting the study.\n10. Normal cardiac function with LVEF ≥50% by echocardiogram or MUGA.\n11. HBV and HCV serology must be performed before including the patient in the study. If HbsAg is positive, it is advisable to rule out a replicative phase (HbsAg\\*, DNA HBV+). If positive, the patient's inclusion in the trial is not recommended, and it is at the discretion of the investigator to administer preventive treatment with lamivudine. If a potential patient is positive to anti-HCV antibodies, the presence of the virus will be ruled out with a qualitative PCR, or the patient cannot be included in the study (if the qualitative PCR test cannot be performed on the patient, they cannot be included in the study).\n12. Patient may have had one previous chemotherapy line (cohort D only).\n13. The patient must have a central venous catheter for the administration of the treatment.\n\nExclusion criteria\n\n1. Unresectable tumours.\n2. Location other than the retroperitoneum.\n3. Patients who have previously received systemic treatment with chemotherapy (trabectedin included). For cohort D, patients may have received one previous line of chemotherapy with any other agent.\n4. Patients who underwent prior local treatment for retroperitoneal sarcoma: surgery or radiotherapy in the tumour bed.\n5. ECOG performance status ≥2.\n6. Presence of metastasis or lymph node involvement of the tumour.\n7. Previous history of another neoplastic disease with less than 5 years free of disease except for basal cell carcinoma or properly treated in situ cervical cancer.\n8. Significant cardiovascular disease (e.g. dyspnoea \\>2 NYHA).\n9. A significant grade 3 or greater systemic disease on the NCI-CTCAE v4.03 scale, which may limit the availability of the patient or which, in the opinion of the investigator, may contribute to the toxicity caused by the study treatment.\n10. Uncontrolled viral, mycotic or bacterial infections.\n11. Known HIV-positive patients.\n12. Pregnant or breast-feeding women.\n13. Psychological, familial, social or geographical circumstances that limit the patient's ability to comply with the protocol or informed consent form.\n14. Patients who have participated in another clinical trial and\u002For have received another investigational product in the 30 days prior to inclusion in the trial.",{"count":1025,"type":18},199,[71,169],"Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients:\n\nCohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma.\n\nCohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma).\n\nCohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component).\n\nPhase I: escalating dose of 1.3 or 1.5 mg\u002Fm2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg\u002Fm2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy\u002Ffraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy\u002Ffraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy\u002Ffraction).\n\nRadiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy\u002Ffraction). A translational substudy is developed to analyse different biomarkers predictive value.\n\nCohorts A and B are closed to recruitment in 2023.",[1029,1030,22,198,451],"Liposarcoma, Myxoid","Sarcoma, Soft Tissue",[1032],"sarcoma","2023-05-29",{"date":1035,"type":31},"2023-05-31",{"date":1037,"type":31},"2014-11",{"date":1014,"type":18},{"name":1040,"class":38},"Grupo Espanol de Investigacion en Sarcomas",17,""]