[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-sarcoma-sts\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-sarcoma-sts":652},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,54,85,103,125,156,182,202,226,248,270,294,327,354,382,401,438,457,482,499,520,562,605,628],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100642407",false,"NCT07630961","Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Age ≥ 18 years old.\n3. ECOG performance status ≤ 2.\n4. Patients with one of the following indications (regardless of lines of prior therapy):\n\n   Locally advanced unresectable or metastatic PDAC, NSCLC, HR+\u002FHER2- ductal or lobular BC, TNBC, CRC or STS.\n5. Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).\n6. Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Out-of-range laboratory values defined as:\n\n   * Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)\n   * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n   * Alanine aminotransferase (ALT) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5.0 x ULN\n   * Aspartate aminotransferase (AST) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5.0 x ULN\n   * Absolute Neutrophil Count \\\u003C 1.0 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Platelet count \\\u003C 75 x 109\u002FL\n2. Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.\n3. Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.\n4. Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and\u002For relevant positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and\u002For 68Ga-NNS309 initiation.\n5. Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n6. Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n7. Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n8. Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.\n9. Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n10. Known additional malignancy that is progressing or requires active treatment.\n11. Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).\n12. Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.\n13. Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety precautions), or interpretation of study results.\n14. Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.\n15. Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and\u002For 68Ga-NNS309 administration, but express and discard breast milk, are eligible.\n16. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate \\\u003C1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.\n\n    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n\n    Highly effective contraception methods include:\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n    * Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example, hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\n    If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent (IC).\n17. Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to prevent them from fathering a child and\u002For to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the IC.\n\nOther protocol-defined inclusion\u002Fexclusioncriteria may apply.","ALL","18 Years",{"count":18,"type":19},66,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DFC413, and in Part 2 compare to \\[68Ga\\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \\[68Ga\\]Ga-DFC413 and \\[68Ga\\]Ga-NNS309), not all indications might be explored.",[25,26,27,28,29,30,31],"Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","Non-small Cell Lung Cancer (NSCLC)","HR+\u002FHER2- Ductal Breast Cancer (BC)","HR+\u002FHER2- Lobular Breast Cancer (BC)","Triple Negative Breast Cancer (TNBC)","Colorectal Cancer (CRC)","Soft Tissue Sarcoma (STS)",[33,34,35,36,37,38,39,40],"metastatic pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","HR+\u002FHER2- ductal breast cancer (BC)","HR+\u002FHER2- lobular breast cancer (BC)","triple negative breast cancer (TNBC)","colorectal cancer (CRC)","soft tissue sarcoma (STS)","radioligand imaging","RECRUITING","2026-06-25",{"date":44,"type":45},"2026-06-26","ACTUAL",{"date":47,"type":45},"2026-06-23",{"date":49,"type":19},"2028-01-22",{"name":51,"class":52},"Novartis Pharmaceuticals","INDUSTRY",1,{"id":55,"slug":4,"hasResults":10,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":10,"sex":15,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":20,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100644347","NCT07662239","Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention","AYA-ONE","Inclusion Criteria:\n\n* Diagnosed with a bone or soft tissue sarcoma\n* Age 15-39 at time of diagnosis\n* Age 15 and older at time of enrollment\n* Age 15-17 at time of enrollment, with assent from participant and consent from parent\u002Flegal guardian\n* Established patient of the DFCI Sarcoma Center or Jimmy Fund\n* Able to read and understand English (to complete required questionnaires and participate in training\u002Fcoaching)\n* Individuals who are not yet adults (teenagers) if they assent and their parents\u002Flegal guardians' consent to participation.\n\nExclusion Criteria:\n\n* Unstable cardiovascular disease in the last 6 months\n* Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, untreated substance use disorder, severe personality disorder)\n* Pregnant\n* Currently participating in physical or occupational therapy\n* Presence of medical conditions or medications that would prohibit participation in an exercise program\n* Meeting exercise guidelines of 150 minutes of moderate intensity\u002F75 minutes of vigorous intensity physical activity per week plus consistent strength training (at least once per week) over the past 3 months. Assessed via Godin Leisure Time Questionnaire by study staff.\n* Adults unable to consent","15 Years","39 Years",{"count":63,"type":19},40,[65],"NA","This study will evaluate strategies to improve physical function and promote exercise and physical activity in adolescents and young adults (AYAs) with sarcoma. The study will assess the feasibility of a standardized triage system for referring AYAs with sarcoma to appropriate exercise and rehabilitation services, and will also examine changes in physical function and health-related quality of life before and after a 12-week personalized exercise program.",[68,69,31],"Sarcoma","Bone Sarcoma",[71,72,73],"sarcoma","bone sarcoma","soft tissue sarcoma","NOT_YET_RECRUITING","2026-06-16",{"date":47,"type":45},{"date":78,"type":19},"2026-08-01",{"date":80,"type":19},"2027-02-01",{"name":82,"class":83},"Dana-Farber Cancer Institute","OTHER",3,{"id":86,"slug":4,"hasResults":10,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":20,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100642582","NCT07650838","OVV-01 Injection Combined With AK112 Injection for the Treatment of Patients With Advanced Soft Tissue Sarcoma (STS)","A Single-Arm, Open-Label, Multicenter Clinical Study Evaluating the Safety and Efficacy of OVV-01 Injection Combined With AK112 Injection in Patients With Advanced Soft Tissue Sarcoma (STS)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures;\n2. Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.\n3. Histologically\u002Fcytologically confirmed metastatic or recurrent unresectable soft tissue sarcoma, currently failing standard therapy (disease progression, recurrence, or intolerance to treatments such as chemotherapy, radiotherapy, or targeted therapy) or lacking standard treatment options. Participants must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies). Subjects must have demonstrated failure or intolerance to anthracycline-based standard chemotherapy regimens. For specific histologic subtypes lacking standard effective chemotherapy options (e.g., alveolar soft part sarcoma), subjects may have previously received targeted therapy (e.g., anti-angiogenic agents such as anlotinib, pazopanib) with failure or intolerance.\n4. Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions with a longest diameter ≥10 mm and lymph node lesions with a shortest diameter ≥15 mm on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound\u002FCT\u002For endoscopic guidance.\n5. ECOG performance status of 0-2, with an estimated survival of at least 12 weeks.\n6. Sufficient organ and hematopoietic function:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 75 × 10⁹\u002FL (no platelet transfusion or thrombopoietin (TPO) therapy within 2 weeks prior to first dose); Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 2 weeks); Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CCr) ≥ 50 mL\u002Fmin; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; for patients with liver metastases, AST and ALT \\\u003C 5 × ULN; Serum total bilirubin (TBIL) ≤ 2 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for at least six months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with known brain metastases and\u002For clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled);\n2. Subjects who received radiotherapy to the target lesion within the past 2 months;\n3. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;\n4. Lesions intended for injection with a maximum diameter \\>100 mm;\n5. Participants who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;\n6. Participants scheduled for or who have previously undergone tissue\u002Forgan transplantation;\n7. Participants with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL; Patients with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at screening, and HBV-DNA above the lower limit of detection; patients with positive HCV antibody at screening and HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;\n8. Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.\n9. Subjects requiring therapeutic anticoagulant therapy during the study period.\n10. Subjects with uncontrolled active infection of ≥Grade 3 severity according to CTCAE v5.0 that is clinically significant;\n11. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose; received nitrosourea or mitomycin C within 6 weeks prior to first dose; palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to first dose);\n12. Uncontrolled hypertension, pulmonary hypertension, or unstable angina; myocardial infarction, coronary artery bypass grafting, or stent placement within 6 months prior to dosing; history of chronic heart failure at New York Heart Association (NYHA) functional class III-IV; Severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia deemed by the investigator as not affecting the trial), including QTcF ≥450 ms in males or ≥470 ms in females (calculated using Fridericia's formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to enrollment;\n13. Active autoimmune disease or history of autoimmune disease with potential for recurrence;\n14. Requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to first dose or during the study period;\n15. Tumors located in high-risk areas (including mucosal regions, proximity to airways, major vessels, or spinal cord) that may cause obstruction or compression due to tumor enlargement, erode major vessels due to necrosis, encase major vascular structures (e.g., carotid artery), tumors adjacent to critical neurovascular structures, or other tumors deemed unsuitable for intratumoral injection;\n16. Subjects requiring administration of any live vaccine during the screening or treatment period;\n17. Subjects with a history of allergy to the study drug, immunotherapy, or any component of related medications;\n18. Subjects with psychiatric disorders, alcoholism, inability to abstain from smoking, drug addiction, or substance abuse;\n19. Pregnant or lactating women;\n20. Adverse reactions to prior antitumor therapy not yet recovered to Grade 1 (CTCAE 5.0) (excluding alopecia);\n21. Severe uncontrolled medical conditions, or other circumstances deemed by the investigator to potentially interfere with study treatment, rendering the subject unsuitable for participation;\n22. Other conditions deemed by the investigator to preclude eligibility.",{"count":63,"type":19},[93],"PHASE2","The efficacy of OVV-01 injection in combination with AK112 injection in subjects with advanced soft tissue sarcoma was evaluated using ORR as the primary endpoint.",[31],"2026-06-14",{"date":75,"type":45},{"date":78,"type":19},{"date":100,"type":19},"2027-12-31",{"name":102,"class":83},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":104,"slug":4,"hasResults":10,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":20,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":53},"100641897","NCT07648069","Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma","A Prospective, Single-center, Double-arm, Phase I Clinical Trial of Tumor Neoantigen Vaccine SarVac Combined With Tumor-specific Lymphocyte Reinfusion in the Treatment of Patients With Advanced or Unresectable Sarcoma-based Solid Tumors Who Failed Standard Treatment.","Inclusion Criteria:\n\n1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n2. Age≥18 years old, and≤70 years old ;\n3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ;\n4. Patients with first-line treatment failure ;\n5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ;\n6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ;\n7. The following three screening indicators should be met in the test screening period:\n\n（1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression.\n\n( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators :\n\n1. White blood cell count ≥ 3.0 × 109 \u002F L;\n2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ;\n3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L;\n4. platelet ( PLT ) ≥ 75 × 109 \u002F L;\n5. hemoglobin ≥ 90g \u002F dL ( no blood transfusion in the past 7 days ) ;\n6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min;\n9. Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN;\n10. Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN;\n11. total bilirubin ( TBIL ) ≤ 1 × ULN 13. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment; 14. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.\n\nExclusion Criteria:\n\n* 1\\. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n\n  2\\. Age≥18 years old, and≤70 years old ; 3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ; 4. Patients with first-line treatment failure ; 5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ; 6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ; 7. The following three screening indicators should be met in the test screening period:\n\n  （1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression.\n\n( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators :\n\n1. White blood cell count ≥ 3.0 × 109 \u002F L;\n2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ;\n3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L;\n4. platelet ( PLT ) ≥ 75 × 109 \u002F L;\n5. hemoglobin ≥ 90g \u002F dL ( no blood transfusion in the past 7 days ) ;\n6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min;\n9. Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN;\n10. Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN;\n11. total bilirubin ( TBIL ) ≤ 1 × ULN 13. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment; 14. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.","70 Years",{"count":111,"type":19},16,[22],"The primary objective of this trial is to evaluate the safety and tolerability of the tumor neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes, in patients with advanced bone and soft tissue sarcoma who have failed first-line treatment. The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, in these patients and to evaluate whether the vaccine's efficacy demonstrates dose dependency.",[31,115],"Osteosarcoma","2026-06-12",{"date":118,"type":45},"2026-06-15",{"date":120,"type":45},"2024-09-03",{"date":122,"type":19},"2027-06-30",{"name":124,"class":83},"Sun Yat-sen University",{"id":126,"slug":4,"hasResults":10,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":20,"phases":133,"briefSummary":134,"conditions":135,"keywords":145,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":53},"100590480","NCT06967961","Research of Double-positive Circulating Cells (Tumor Marker \u002F CD45+) in Several Types of Metastatic Cancers","DP-PAN-CANCER","Inclusion Criteria:\n\n* 1\\. Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors\n* 2\\. Metastatic disease for which the treatment (whatever the line) has not been initiated yet\n* 3\\. Age ≥ 18 years\n* 4\\. Patient affiliated to a French Social Security scheme\n* 5\\. Patient having signed his\u002Fher informed consent prior to inclusion in the study and prior to any specific procedure for the study.\n\nExclusion Criteria:\n\n* 1\\. Patient with localized disease.\n* 2\\. Pregnant or breast-feeding women.\n* 3\\. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and\u002For procedures set out in the study protocol.\n* 4\\. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":132,"type":19},450,[65],"A prospective, proof-of-concept pilot study in patients with metastatic cancers (9 types of cancers are studied) treated at the IUCT-O or possibly in other institutions. Eligible patients will be selected and informed of this study during a medical consultation for their cancer by medical oncologists. Then, with the patient's consent and before the start of anti-cancer treatment (whatever the line), a blood sample will be taken to detect DP-circulating cells by 2 different methods of analysis.\n\nEach patient will participate in the study for one day. The methods of analysis will be: flow cytometry for all patients and either Parsotix® or CellSearch® depending on the type of cancer.\n\n450 patients will be enrolled in total.",[136,137,138,139,140,31,141,142,143,144],"Urothelial Carcinoma","Renal Cancer","Prostate Adenocarcinoma","Adenocarcinoma of Endometrium","Cutaneous Melanoma","Nonseminomatous Germ Cell Tumor","Seminomatous Germ Cell Tumor","Upper Aerodigestive Tract Carcinoma","Cervical Carcinoma",[146,147,148],"metastatic cancers","Double Positive Circulating cells","liquid biopsy",{"date":118,"type":45},{"date":151,"type":45},"2025-07-23",{"date":153,"type":19},"2029-07-23",{"name":155,"class":83},"Institut Claudius Regaud",{"id":157,"slug":4,"hasResults":10,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":10,"sex":15,"minAge":60,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":20,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":53},"100641009","NCT07612098","Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma","A Prospective Multicenter Randomized Controlled Study of Preoperative Radiotherapy Combined With Targeted Therapy With or Without Immunotherapy for Soft Tissue Sarcoma","SPARE-04","Inclusion Criteria:\n\n* Primary or recurrent soft tissue sarcoma of the extremity or trunk with intermediate- to high-grade disease and tumor size \\>=5 cm or deep-seated tumor, for which radiotherapy is recommended after multidisciplinary evaluation.\n* Age \\>=15 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.\n* Histologically confirmed soft tissue sarcoma.\n* At least one evaluable lesion.\n* Able to tolerate radiotherapy, anlotinib, and penpulimab treatment.\n* Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use effective contraception during the treatment period and for 6 months after the last dose of study treatment.\n* Able to provide written informed consent.\n* Able and willing to comply with follow-up.\n\nExclusion Criteria:\n\n* No gross tumor remaining after unplanned tumor resection performed at another hospital.\n* Contraindications to targeted therapy or immunotherapy due to comorbidities, including allergy, autoimmune disease, active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrolled hypertension, New York Heart Association class III-IV cardiac dysfunction, or severe hepatic or renal dysfunction.\n* Dermatofibrosarcoma protuberans, desmoid fibromatosis, tenosynovial giant cell tumor, or other locally aggressive diseases.\n* Benign tumors.\n* Sarcoma subtypes for which chemotherapy is recommended as the preferred neoadjuvant treatment according to guidelines, such as embryonal rhabdomyosarcoma or Ewing sarcoma.\n* Lipoma-like liposarcoma or well-differentiated liposarcoma.\n* New malignant tumor within 5 years before enrollment, except cervical carcinoma in situ, early-stage basal cell carcinoma of the skin, or early-stage lung cancer.\n* Soft tissue sarcoma that can be cured by wide local excision alone.\n* Prior radiotherapy to the same anatomical site.\n* Other severe medical comorbidities that would preclude surgery or participation in this study.",{"count":164,"type":19},274,[93],"Soft tissue sarcoma is a rare cancer that often requires surgery combined with radiotherapy. Preoperative radiotherapy can improve the chance of complete tumor removal and limb preservation, but some patients still experience local recurrence, distant metastasis, or poor tumor response.\n\nThis is a prospective, multicenter, randomized phase II study for patients with localized soft tissue sarcoma of the extremity or trunk who need preoperative radiotherapy. Participants will be randomly assigned to receive preoperative radiotherapy plus anlotinib, or preoperative radiotherapy plus anlotinib and penpulimab. Surgery will be performed after completion of neoadjuvant treatment according to the study protocol.\n\nThe main purpose of this study is to evaluate whether adding penpulimab to preoperative radiotherapy and anlotinib can improve 3-year disease-free survival. The study will also assess pathological response, wound complications, treatment-related adverse events, local control, distant metastasis-free survival, overall survival, limb function, quality of life, and exploratory biomarkers related to treatment response.",[31],[169,170,171,172,173],"Soft Tissue Sarcoma","Preoperative Radiotherapy","Neoadjuvant Therapy","Anlotinib","Penpulimab","2026-05-21",{"date":176,"type":45},"2026-05-28",{"date":178,"type":19},"2026-07-01",{"date":180,"type":19},"2031-12-31",{"name":102,"class":83},{"id":183,"slug":4,"hasResults":10,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":10,"sex":15,"minAge":188,"maxAge":109,"enrollmentInfo":189,"targetDuration":4,"studyType":20,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":53},"100639048","NCT07602049","Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma","A Prospective, Single-Center, Single-Arm Phase II Clinical Trial of Cryoablation Combined With Camrelizumab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma Refractory to Standard Therapy","Inclusion Criteria:\n\n1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n2. Age≥14 years old, and≤70 years old ;\n3. Pathologically diagnosed as soft tissue sarcomas, and staging for advanced or unresectable patients ;\n4. Patients with standard treatment (such as chemotherapy) failure ;\n5. No previous treatment with PD-1 antibody ; or those who have previously received PD-1 antibody therapy and progressed at least half a year later;\n6. According to the RECIST1.1 standard, there are ≥3 measurable lesions; the distribution sites of multiple lesions are in ≤3 organs (which may include the abdominopelvic cavity, extremities, liver, lungs, pleura, etc.); the size of the target lesions is 1.0 - 5.0 cm.\n7. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 3 months ;\n8. Patients with brain metastasis who were stable for at least one month after treatment and who do not require the use of glucocorticoids can be included.\n9. echocardiography showed left ventricular ejection fraction ≥ 50 %;\n10. The results of laboratory tests should meet at least the following indicators :\n\n（1）White blood cell count ≥ 3.0 × 109 \u002F L; （2）absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ; （3）absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L; （4）platelet ( PLT ) ≥ 75 × 109 \u002F L; （5）hemoglobin ≥ 10g \u002F dL ( no blood transfusion in the past 7 days ) ; （6）Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （7）partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （8）serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min; （9）Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （10）Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （11）total bilirubin ( TBIL ) ≤ 1 × ULN 11. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment.\n\n12\\. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.\n\nExclusion Criteria:\n\n1. Concurrently having other malignant tumors within 5 years.;\n2. Patients who received major surgeries, conventional chemotherapy, large-area radiotherapy, biotherapy or interventional ablation therapy for anti-tumor treatment within 4 weeks before entering the trial;\n3. known for any component of this test treatment will produce allergic reactions ;\n4. No recovery from previous surgery or treatment-related adverse reactions to \\\u003C Level 2 CTCAE;\n5. Uncontrolled hypertension ( systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 90 mmHg ) or clinically significant cardiovascular and cerebrovascular diseases ( such as activity ), such as cerebrovascular accident ( within 6 months before the signing of informed consent ), myocardial infarction ( within 6 months before the signing of informed consent ), unstable angina, New York Heart Association ( Appendix ) grade II or above congestive heart failure, or severe arrhythmia can not be controlled with drugs or have a potential impact on research and treatment ; the electrocardiogram showed obvious abnormality or average QTc interval ≥ 450 milliseconds in three consecutive times.\n6. Combined with other serious organic diseases and mental disorders;\n7. Patients with systemic active infections requiring treatment, including active tuberculosis, known HIV-positive patients or clinically active hepatitis A, B, and C patients, in the case of chronic hepatitis B virus infection, the HBV-DNA level should be ≤ 10E3.\n8. Patients with autoimmune diseases : patients with a history of inflammatory bowel disease and a history of autoimmune diseases ( such as systemic lupus erythematosus, vasculitis, and invasive lung disease ) that were judged by the researchers to be unsuitable for this study need to be excluded. (Patients with vitiligo and those with Hashimoto's thyroiditis with normal thyroid function will not be excluded.)\n9. During the 4 weeks prior to therapy, if there has been use of chronic systemic corticosteroids, hydroxyurea, immunomodulatory drugs (such as interleukin-2, α or γ interferons, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.).\n10. History of organ transplantation, autologous \u002F allogeneic stem cell transplantation and renal replacement therapy;\n11. known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;\n12. Known alcohol and\u002For drug abuse;\n13. Pregnant or lactating women;\n14. With any researchers determine that may damage the test carried out in the coexistence of medical conditions or diseases of the test;\n15. No legal capacity \u002F limited capacity.","14 Years",{"count":190,"type":19},57,[93],"The main purpose of this trial is to investigate and evaluate the efficacy of cryoablation combined with camrelizumab treatment to patients with advanced or inoperable soft tissue sarcomas after standard treatment failure.",[31,115],"2026-05-20",{"date":196,"type":45},"2026-05-22",{"date":198,"type":45},"2024-11-20",{"date":200,"type":19},"2027-11-30",{"name":124,"class":83},{"id":203,"slug":4,"hasResults":10,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":109,"enrollmentInfo":208,"targetDuration":4,"studyType":20,"phases":210,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":53},"100591425","NCT06980259","Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma","Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma:A Multicenter，Prospective, Phase II, Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. Age 18-70 years, irrespective of gender. 2. Pathologically or clinically confirmed diagnosis of soft tissue sarcoma. 3. Minimum tumor diameter ≥5 cm. 4. Receiving systemic treatment as per multidisciplinary team (MDT) recommendations.\n\n  5\\. Measurable lesion (per RECIST 1.1\u002FChoi criteria: longest diameter \\>1.5 cm, or \\>1 cm with two measurable perpendicular diameters).\n\n  6\\. ECOG performance status ≤2. 7. Expected survival ≥3 months. 8. Normal liver, kidney, lung, and cardiac function, with tolerance for treatment.\n\n  9\\. Patients of childbearing potential agree to use reliable contraception during treatment and for one year thereafter.\n\n  10\\. Voluntary provision of signed informed consent.\n\nExclusion Criteria:\n\n* (1) Patients with a second primary malignancy. (2) Diagnosis of aggressive fibromatosis or rhabdomyosarcoma. (3) Prior radiotherapy to the target lesion. (4) Tumor unsuitable for radiotherapy. (5) Severe liver, kidney, lung, or cardiac dysfunction, precluding tolerance to systemic therapy or radiotherapy.\n\n  (6) Other severe medical conditions that may impact the study (e.g., uncontrolled diabetes, gastric ulcers, or other serious cardiopulmonary diseases).\n\n  (7) Severe or uncontrolled infections, or active autoimmune diseases. (8) Clinically evident central nervous system dysfunction. (9) Pregnant or lactating women, or women of childbearing potential not using contraception.\n\n  (10) Other conditions deemed unsuitable for participation by the investigator.",{"count":209,"type":19},106,[65],"This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0), and quality of life (QoL, assessed by EORTC QLQ-C30). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.\n\nThis study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.",[31],[169,214,215,216],"Spatially Fractionated Radiotherapy","Objective Response Rate","Conventional Radiotherapy","2026-04-27",{"date":219,"type":45},"2026-04-28",{"date":221,"type":45},"2025-05-20",{"date":223,"type":19},"2028-05-20",{"name":225,"class":83},"Shandong Cancer Hospital and Institute",{"id":227,"slug":4,"hasResults":10,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":10,"sex":15,"minAge":233,"maxAge":109,"enrollmentInfo":234,"targetDuration":4,"studyType":20,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":53},"100595425","NCT07032285","Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas","Multicenter, Open-Label Phase II Trial of Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas","CIRTUSARC","Inclusion criteria:\n\n1. Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow up. Informed consent must be obtained prior to the start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g., imaging tests), obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.\n2. Age: 16-70 years.\n3. Patients with a diagnosis of advanced unresectable soft-tissue sarcoma and not candidates for surgical rescue including only the following subtypes: solitary fibrous tumor (SFT), synovial sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma (EMC), alveolar soft part sarcoma and myxoid liposarcoma. Additionally, the Hospital Universitario Fundación Jiménez Díaz will include 2 desmoid tumor patients as proof of concept outside the total n.\n4. Metastatic\u002Flocally advanced with recent progression (\\\u003C6 months).\n5. Patients should have received at least anthracyclines previously unless not indicated (SFT).\n6. Measurable disease according to RECIST 1.1 criteria.\n7. Patients must be willing to provide consent for the provision of mandatory biological samples for central pathology review (tumor sample from the three months prior to the start of treatment if the patient has not received any systemic therapy) and translational study (tumor blocks and blood).\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n9. Adequate hepatic, renal, cardiac, and hematologic function.\n10. Laboratory tests as follows:\n\n    * Absolute neutrophil count ≥1,500\u002Fmm³\n    * Platelet count ≥100,000\u002Fmm³\n    * Bilirubin ≤1.5 mg\u002FdL\n    * AST and ALT ≤2.5 times upper limit of normal\n    * Creatinine ≤1.5 mg\u002FdL\n11. Left ventricular ejection fraction ≥50% by echocardiogram or MUGA scan.\n12. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and agree to use birth control measures during study treatment and for 3 months after its completion. Patients must not be pregnant or nursing at study entry. Women\u002Fmen of reproductive potential must have agreed to use a highly effective contraceptive method.\n13. Subjects must be willing to avoid extensive sun exposure, phototherapy, and use of a tanning salon during trial participation.\n\nExclusion criteria:\n\nPatients meeting any of the following exclusion criteria are not eligible to be enrolled in this study:\n\n1. Previous treatment with CLK inhibitors.\n2. Patients who have received any other anti-cancer therapy or investigational product in the last 28 days prior to enrollment.\n3. Four or more systemic therapy lines for advanced disease.\n4. Sarcoma subtypes other than the specified in the inclusion criteria.\n5. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 3 years prior to enrollment. Cancer treated with curative intent for \\>5 years previously and without evidence of recurrence will be allowed.\n6. Any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.\n7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.\n8. Pregnant or breastfeeding females.\n9. Body surface area (BSA) \\\u003C1.4 m2 at baseline, calculated by the Du Bois (33) or Mosteller (34) method.\n10. Life expectancy of less than 3 months.\n11. Major surgery within 28 days prior to C1D1.\n12. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.\n13. Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia\u002Fcachexia (palliative care).\n14. Any active, serious psychiatric, medical, or other conditions\u002Fsituations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.\n15. Subjects with a corrected QT interval (QTc) using Fridericia's formula (QTcF) \\> CTCAE v5.0 Grade 1 (\\>480 msec) based on the mean of triplicate evaluation at screening. In subjects with ventricular paced rhythm, a 50 msec subtraction should be applied to the QTc to calculate the QTcF, potential exceptions for subjects with pacemakers should be discussed with the Medical Monitor.\n16. Subjects with clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), ventricular fibrillation (VF), second or third degree heart block.\n17. Subjects with myocardial infarction (MI) within 1 year, Class II-IV congestive heart failure (CHF) per New York Heart Association (NYHA) classification, or clinically significant coronary artery disease (CAD).\n18. Subjects currently using or anticipating the need for food or drugs known to strongly inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 10 days prior to first dose of study medication.\n19. Subjects with retinal abnormalities, specifically diabetic retinopathy, macular degeneration, other forms of retinal degenerative disease, or other retinal findings that may place the subject at risk (the latter should be discussed with the Medical Monitor).\n20. Subjects with known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.\n21. Patient is unwilling to participate in the translational study (not providing mandatory written consent for tumor and blood samples).","16 Years",{"count":235,"type":19},25,[93],"The study is a Phase 2 clinical trial of the drug cirtuvivint as a second-line treatment for advanced soft tissue sarcomas. The study is being conducted in Spain and is expected to enroll approximately 25 patients in total. The primary objective of this Phase 2 study is to evaluate the efficacy of treatment with cirtuvivint.\n\nCirtuvivint is an anti-cancer medication developed by the U.S. company Biosplice Therapeutics, Inc. This drug is an inhibitor of the enzymes CLK1-4 and DYRK1-4 (molecules involved in the cell cycle) and is administered as oral tablets. This product is still under investigation and has not yet been approved in Europe.",[31],"2026-03-31",{"date":241,"type":45},"2026-04-06",{"date":243,"type":45},"2025-01-15",{"date":245,"type":19},"2027-07-30",{"name":247,"class":83},"Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas",{"id":249,"slug":4,"hasResults":10,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":20,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":53},"100578774","NCT06815666","BAL Fluid Biomarkers in Sarcoma","Prospective Study of Biomarkers Derived From Bronchoalveolar Lavage Fluid to Predict Outcomes in Soft-Tissue Sarcomas","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to understand and willingness to sign a written informed consent document\n3. Diagnosed with soft tissue sarcoma\n4. Undergoing resection of lung lesion as part of standard care\n\nExclusion Criteria:\n\n1\\. History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years",{"count":255,"type":19},70,[93],"This is a single-centre, Phase II, prospective study designed to assess BALF and TA-derived biomarkers in relation to metastatic burden in STS patients. BALF and TA samples will be collected during routine bronchoscopy performed as part of standard care at Toronto General Hospital (TGH). Additionally, tissue samples of lung metastases and adjacent normal lung will be collected and used to correlate the identified biomarkers.",[31,259,260],"Bronchoalveolar Lavage (BAL)","Bronchoalveolar Lavage Fluid","2026-03-03",{"date":263,"type":45},"2026-03-04",{"date":265,"type":45},"2025-01-29",{"date":267,"type":19},"2032-04-01",{"name":269,"class":83},"University Health Network, Toronto",{"id":271,"slug":4,"hasResults":10,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":20,"phases":279,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":53},"100595886","NCT07038278","5-AminoLevulinic Acid Aided Resection Margins in Sarcoma","5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (5-ALARMS)","5-ALARMS","Inclusion Criteria:\n\n1. Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC).\n2. Treatment decision includes planned surgical resection of STS.\n3. Age ≥18 years at time of consent.\n4. ECOG Performance Status 0 - 1.\n5. Hematology and blood chemistry parameters defined by:\n\n   1. Leukocytes ≥ 3 × 10(9)\u002FL\n   2. Absolute neutrophil count ≥ 1.5 × 10(9)\u002FL\n   3. Platelets ≥ 100 × 109\u002FL, transfusions may be used to raise platelets to ≥ 100 × 10(9)\u002FL (no washout required)\n   4. Hemoglobin ≥ 9 g\u002FdL, transfusions may be used to raise Hgb to ≥ 9 g\u002FdL (no washout required)\n   5. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n   6. Aspartate transaminase (AST) \u002F alanine transaminase (ALT) ≤ 2.5 × institutional ULN\n   7. Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73 m2 for patients with creatinine above institutional ULN\n6. Participants of reproductive potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 42 days after end of study intervention; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy).\n7. Ability to swallow study agent.\n8. Ability to understand and willingness to sign an informed consent form.\n9. Ability and stated willingness to adhere to the study visit schedule and other protocol procedures\u002Frequirements for the duration of the study.\n\nInclusion of Minorities and Other Underrepresented Populations Recruitment is open and encouraged to all genders, all minorities, and underrepresented populations. Although distributions may vary by disease type, our recruitment procedures have been developed to enroll participants who are representative of the respective target population.\n\nExclusion Criteria:\n\n1. Acute\u002Fchronic forms of porphyria.\n2. Uncontrolled, known concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.\n3. Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.\n4. Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.\n5. Planned use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones and tetracyclines), and topical preparations containing aminolevulinic acid (5-ALA) for 24 hours during the perioperative period (defined as 24 hours prior to surgery to up to 24 hours post-surgery).\n6. Pregnant or planning to become pregnant during study participation or breastfeeding.\n7. Any condition that is in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial.",{"count":278,"type":19},20,[280],"EARLY_PHASE1","The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.",[31],[73,284],"fluorescence","2026-02-25",{"date":287,"type":45},"2026-02-27",{"date":289,"type":19},"2026-04-01",{"date":291,"type":19},"2028-11-01",{"name":293,"class":83},"University of Colorado, Denver",{"id":295,"slug":4,"hasResults":10,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":302,"phases":4,"briefSummary":303,"conditions":304,"keywords":315,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":53},"100626230","NCT07432932","Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients","PANTHR-S","Inclusion Criteria:\n\n* Written informed consent for the prospective cohort\n\n  * Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.\n  * High-risk sarcoma definition:\n\n    * Greater than 5cm or Grade 3\n    * Deep anatomic location\n  * Have disease amenable to biopsy\n\n    o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study\n  * Resectable tumour\n  * Measurable disease by RECIST 1.1\n  * Aged ≥ 18 years\n  * WHO performance status 0-2\n  * For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy\n  * Patients medically fit enough to undergo surgical resection\n  * Capable of giving written informed consent (for prospective cohort) and comply with the study schedule\n  * Patients may also participate in the STRASS 2 trial\n\nExclusion Criteria:\n\n-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.\n\n* Known additional malignancy that is progressing or requires active treatment\n* Metastatic disease not amenable to curative intent local therapy\n* Any active uncontrolled medical conditions",{"count":301,"type":19},800,"OBSERVATIONAL","This is a cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) in high-risk soft tissue sarcoma (STS) patients with dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS), synovial sarcoma (SS), vascular sarcomas, malignant peripheral nerve sheath tumour (MPNST) or other subtypes. It comprises of both retrospective and prospective tissue collection from patients advancing directly to surgery (control group) and patients receiving NCT and surgery.",[68,305,306,31,307,308,309,310,311,312,313,314],"Sarcoma, Leiomyo-, Adult","Sarcoma, Synovial, Adult","Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma of the Trunk and Extremities","Soft Tissue Sarcoma of the Limb","Retroperitoneal Sarcoma","Liposarcoma, Dedifferentiated","Liposarcoma","Leiomyosarcoma (LMS)","Angiosarcoma",[316,317,318],"PANTHRS","PANTHRS-S","Sarcoma Accelerator","2026-02-18",{"date":285,"type":45},{"date":322,"type":45},"2021-11-19",{"date":324,"type":19},"2028-06-30",{"name":326,"class":83},"Royal Marsden NHS Foundation Trust",{"id":328,"slug":4,"hasResults":10,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":20,"phases":336,"briefSummary":337,"conditions":338,"keywords":342,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":351,"leadSponsor":353,"locationsCount":53},"100623398","NCT07396116","Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02)","Preoperative Hypofractionated Radiotherapy Combined With Immunotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-02)","FUSION-02","Inclusion Criteria:\n\n* Diagnosis \\& Indication: Primary or recurrent abdominopelvic soft tissue sarcoma. Patients are deemed to have a high probability of R1\u002FR2 resection with upfront surgery and are confirmed to require radiotherapy following Multidisciplinary Team (MDT) discussion.\n* Target Volume: In cases of multifocal disease, all lesions must be safely encompassable within a single radiotherapy target volume.\n* Age: Age ≥ 18 years.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0-2; American Society of Anesthesiologists (ASA) score ≤ 2; patients must be expected to tolerate surgery and radiotherapy.\n* Pathology: Histologically confirmed soft tissue sarcoma.\n* Measurability: Presence of evaluable lesions.\n* Life Expectancy: Life expectancy \\> 5 years.\n* Hematological \\& Hepatic Function: Adequate organ function\n* Renal Function: Adequate renal function defined as Glomerular Filtration Rate (GFR) ≥ 50 ml\u002Fmin (calculated by Cockcroft-Gault formula), and split renal function imaging confirms function in the contralateral kidney.\n* Contraception: Female patients of childbearing potential, or male patients with female partners of childbearing potential, must agree to use effective contraception during the entire treatment period and for 6 months after the last dose.\n* Consent: Signed informed consent form.\n* Follow-up: Capable of complying with follow-up requirements.\n\nExclusion Criteria:\n\n* Significant Comorbidities: Patients with the following concurrent conditions: active hemorrhage, ulceration, intestinal perforation, intestinal obstruction, uncontrolled hypertension, cardiac insufficiency (NYHA Class III-IV), severe hepatic or renal dysfunction (Grade 4), mesenteric ischemia, or severe inflammatory bowel disease (IBD).\n* Excluded Histologies: Other pathological types, including Gastrointestinal Stromal Tumor (GIST), sarcomatoid carcinoma, sarcomas primarily treated with chemotherapy (e.g., rhabdomyosarcoma and PNET), desmoid fibromatosis, and benign tumors.\n* Unresectability: Tumor invasion into critical structures such as the liver, pancreatic head, or abdominal aorta, rendering the tumor deemed unresectable.\n* Prior Radiotherapy: History of prior radiotherapy to the same anatomical region.\n* Distant Metastasis: Presence of distant metastasis (M1) confirmed by comprehensive imaging\u002Fexamination within 4 weeks prior to enrollment.\n* Contraindications to Surgery\u002FProtocol: Presence of other severe medical comorbidities that contraindicate surgery or preclude participation in the study.\n* Planned Neoadjuvant Chemotherapy: Patients scheduled to receive (concurrent) neoadjuvant chemotherapy.\n* Recent Systemic Therapy: Receipt of chemotherapy or other systemic treatments within 4 weeks prior to enrollment.",{"count":335,"type":19},28,[65],"To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma",[31,310,339,340,341],"Immunotherapy","Radiotherapy Side Effect","Ultra-hypofractionated Radiotherapy",[343,344,73,345,346],"hypofractionated radiotherapy","retroperitoneal sarcoma","immunotherapy","peri-operative complications","2026-02-10",{"date":349,"type":45},"2026-02-12",{"date":349,"type":19},{"date":352,"type":19},"2028-12-31",{"name":102,"class":83},{"id":355,"slug":4,"hasResults":10,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":20,"phases":362,"briefSummary":363,"conditions":364,"keywords":370,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":379,"locationsCount":381},"100606316","NCT07173972","Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.","PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-2","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).\n3. Measurable disease according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. For patients with metastatic disease a life-expectancy greater than 2 years should be expected.\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 Proton Beam radiotherapy.\n\nExclusion Criteria:\n\n1. Patients with a 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.\n2. Previous radiotherapy to the tumor site.\n3. Patients with pacemakers and\u002For implanted defibrillators.\n4. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.",{"count":63,"type":19},[93],"The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects.\n\nThe planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction).\n\nAt the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life.\n\nThe study will be conducted in Norway, with a planned inclusion of 40 patients.",[31,307,308,365,366,367,313,368,369,312],"Synovial Sarcomas","Undifferentiated Pleomorphic Sarcoma (UPS)","Myxofibrosarcoma","Pleomorphic Liposarcoma","Pleomorphic Rhabdomyosarcoma",[73,371,372],"proton radiotherapy","inoperable soft tissue sarcoma","2026-01-26",{"date":375,"type":45},"2026-01-28",{"date":373,"type":45},{"date":378,"type":19},"2035-11-01",{"name":380,"class":83},"Oslo University Hospital",2,{"id":383,"slug":4,"hasResults":10,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":20,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":53},"100619261","NCT07342322","A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With the PraG Strategy for the Treatment of Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age: 18-75 years old, both genders are eligible.\n2. Pathological Diagnosis: Histologically confirmed soft tissue sarcoma, including but not limited to:\n\n   * Undifferentiated pleomorphic sarcoma\n   * Liposarcoma\n   * Leiomyosarcoma\n   * Synovial sarcoma\n   * Fibrosarcoma\n   * Other high-grade soft tissue sarcomas\n3. Disease Stage:\n\n   * Locally advanced, unresectable soft tissue sarcoma, or\n   * Recurrent or metastatic soft tissue sarcoma\n4. Prior Therapy:\n\n   * Prior surgery, radiotherapy, or chemotherapy is allowed.\n   * At least 4 weeks since the last anti-tumor treatment.\n   * Prior treatment-related toxicities have resolved to ≤Grade 1 (except alopecia).\n5. Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria.\n6. Performance Status: ECOG performance status score of 0-2.\n7. Life Expectancy: ≥3 months.\n8. Organ Function:\n\n   * Hematology: Hemoglobin ≥50 g\u002FL, absolute neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥60×10⁹\u002FL\n   * Liver Function: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastasis)\n   * Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL\u002Fmin\n   * Cardiac Function: Left ventricular ejection fraction ≥40%\n9. Informed Consent: The patient or their legal representative has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Special Types of Sarcoma:\n\n   * Gastrointestinal Stromal Tumor (GIST)\n   * Osteosarcoma\n   * Ewing's Sarcoma\n2. Prior Treatment History:\n\n   * Previous radiotherapy to the same site with a cumulative dose that may exceed the normal tissue tolerance dose\n   * Major surgery within 4 weeks\n3. Concurrent Diseases:\n\n   * Active autoimmune diseases\n   * Diseases requiring systemic immunosuppressive therapy\n   * Severe cardiovascular diseases (myocardial infarction, unstable angina, heart failure, etc.)\n   * Severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, etc.)\n   * Active infections requiring systemic anti-infective therapy\n4. Central Nervous System Metastasis: Symptomatic brain or spinal metastasis.\n5. Pregnancy and Lactation: Women who are pregnant or breastfeeding.\n6. Allergy History: Known allergies to the drugs or their components involved in the study.","75 Years",{"count":235,"type":19},[93],"The primary objective of this clinical trial is to evaluate the efficacy and safety of spatially fractionated radiotherapy combined with the PraG strategy in the treatment of soft tissue sarcoma (STS). The main questions it aims to answer are:\n\n1. Can spatially fractionated radiotherapy combined with the PraG strategy improve the clinical prognosis of patients?\n2. What medical adverse events and clinical problems will participants encounter during the treatment with spatially fractionated radiotherapy combined with the PraG strategy? Researchers will administer a combined therapeutic regimen consisting of spatially fractionated radiotherapy, Toripalimab, recombinant human granulocyte-macrophage colony-stimulating factor injection, and Thymalfasin injection to enrolled patients, so as to observe the efficacy and safety of this therapeutic strategy for soft tissue sarcoma.\n\nParticipants will:\n\n1. The treatment will be divided into two major phases: the radiotherapy phase and the immunotherapy phase, with concomitant immunomodulatory supportive therapy administered throughout the entire treatment course.\n2. The total duration of treatment will last for 1 year starting from the first dose of medication, with regular clinical evaluations conducted according to the individual disease characteristics of each patient.\n3. Participants will receive daily oral administration of ABC or placebo for a consecutive 4 months.\n4. Routine follow-up examinations will be performed at an interval of 8\u002F12 weeks.\n5. Clinical symptoms, imaging indicators, biochemical parameters and survival status of all participants will be systematically recorded and documented throughout the study period.",[31],"2026-01-08",{"date":394,"type":45},"2026-01-15",{"date":396,"type":19},"2026-02-01",{"date":398,"type":19},"2029-01-31",{"name":400,"class":83},"First Affiliated Hospital of Guangxi Medical University",{"id":402,"slug":4,"hasResults":10,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":20,"phases":410,"briefSummary":411,"conditions":412,"keywords":425,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":53},"100565717","NCT06645808","PET-imaging of Two Vartumabs in Patients With Solid Tumors","The Safety, Tolerability and Biodistribution of a Single Intravenous Administration of Two Zirconium-89 Labelled Vartumabs (F8scFV or C9scFv) in Patients With Solid Tumors - a Phase 0, Open Label, PET\u002FCT Molecular Imaging Basket Trial","VARTUTRACE","General Inclusion Criteria:\n\n1. Willing to adhere to the prohibitions and restrictions specified in this protocol.\n2. Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol.\n3. Patients aged ≥ 18 years at moment of signing informed consent form.\n4. Life expectancy of \\> 12 weeks.\n5. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n6. BMI ≥ 18.0 and ≤ 35.0 kg\u002Fm2 and weight at least 50 kg and no more than 120 kg at screening.\n7. Overtly healthy based on medical history, physical findings, vital signs, ECG at the time of screening, as judged by the Investigator. Note: one retest of vital functions and ECG is allowed within the screening window.\n8. Adequate liver- and kidney function, defined by the following laboratory results obtained during screening visit:\n\n   * AST, ALT, and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN) as determined by the UMCG laboratory reference values.\n   * Serum bilirubin ≤ 2.0x ULN as determined by the UMCG laboratory reference values. Patients with known Gilbert disease who have serum bilirubin level ≤ 3x ULN may be enrolled.\n   * INR or APTT ≤ 1.5x ULN as determined by the UMCG laboratory reference values. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n   * eGFR (based on plasma-creatinine) = \\>30 mL\u002Fmin.\n   * Serum albumin \\>35 g\u002FL.\n9. No other clinically significant laboratory abnormalities as determined by the investigator. Note: one retest of lab tests is allowed within the screening window.\n10. Female patients should be at least 1 year post-menopausal (amenorrhea \\>12 months and\u002For follicle-stimulating hormone \\>30 mIU\u002FmL) at screening or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation).\n11. Male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control, and must not donate sperm, until 3 months after administration of 89Zr-DFO-N-Suc-scFv (F8 or C9).\n\nMedical inclusion Criteria:\n\nColon Carcinoma:\n\n1. Patients diagnosed with colon carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of colon carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nRectal Carcinoma:\n\n1. Patients diagnosed with rectal carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of rectal carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBone- and soft-tissue sarcoma\n\n1. Patients diagnosed with a bone- or soft-tissue sarcoma stage I-IV, according to AJCC staging for Sarcoma.\n2. Histologically confirmed diagnosis of sarcoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBreast carcinoma\n\n1. Patients diagnosed with breast carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of breast carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nLung Carcinoma:\n\n1. Anticipated diagnosis of Non-Small Cell Lung Carcinoma (NSCLC) stage I-IV, according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)\u002FCT or based on cytology.\n2. Neo-adjuvant treatment according to the standard of care.\n\nHead and Neck Squamous Cell carcinoma (HNSCC):\n\n1. Patients diagnosed with HNSCC of the oral cavity, oropharynx, nasal cavity, nasopharynx, hypopharynx and larynx.\n2. Histologically confirmed diagnosis of HNSCC.\n3. Neo-adjuvant treatment according to the standard of care.\n\nOesophageal and gastric carcinoma:\n\n1. Patients diagnosed with oesophagus carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n2. Patients diagnosed with gastric carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n3. Histologically confirmed diagnosis of oesophageal- or gastric carcinoma.\n4. Neo-adjuvant treatment according to the standard of care.\n\nPancreas carcinoma:\n\n1. Anticipated diagnosis of pancreas carcinoma stage I-IV according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)\u002FCT or based on cytology.\n2. Histologically or cytologically confirmed diagnosis of pancreas carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBladder carcinoma:\n\n1. Patients diagnosed with invasive bladder carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of bladder carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nGlioblastoma:\n\n1. Anticipated diagnosis of a high-grade glioma (glioblastoma, grade 4 according to the WHO classification) based on imaging modalities such as MRI and\u002For CT or a biopsy.\n2. Karnofsky performance status of at least 70%.\n3. Neo-adjuvant treatment according to the standard of care.\n\nGeneral Exclusion Criteria:\n\n1. Behavioral or cognitive impairment or psychiatric disease that, in the investigator's opinion, affects the patient's ability to understand and cooperate with the study protocol.\n2. Insufficient venous access for the study procedures.\n3. Close affiliation with the investigator, e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of surgery or nuclear department of the UMCG,TRACER or affiliates.\n4. Any finding in the medical examinations or medical history giving, in the opinion of the investigator, reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications.\n5. Participation in an interventional clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins and minerals) or medical device.\n\nMedical Exclusion Criteria:\n\n1. The existence of a second concomitant active malignancy or treatment for a second malignancy within 1 year prior to IMP-administration that is not a solid tumor indication included in the VARTUTRACE study, except for localized basal or squamous cell cancer that has been cured at least 90 days before screening.\n2. Cardiac impairment with an estimated LVEF \\\u003C35 % Prolonged QTcF (\\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator.\n3. Any abnormalities in the vital signs of the patient, as judged by the investigator, as a result of which the patient cannot participate. Note: One retest of vital functions is allowed within the screening window.\n4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.\n5. Major surgical procedure other than for the included diagnosis within four weeks before IMP administration. Disease-related procedures, e.g. the placement of a port-a-cath, placement of a drain, ERCP, are allowed.\n6. Current evidence or history of bacterial, viral or fungal infections within 7 days before 89Zr-DFON-Suc-scFv (F8 or C9) administration as judged by the Investigator.\n\n   * T \\> 38.0°C or lab confirmed viral\u002Fbacterial\u002Ffungal infection (PCR) or symptoms suggestive of an infection)\n   * Received oral or IV antibiotics within \\\u003C7 days before administration.\n7. Any planned major surgery within the duration of the study (until follow-up visit) that is not related to the tumor, with the exception of any emergency surgeries.\n8. Prior allogeneic bone marrow transplantation or solid organ transplant.\n9. A history of anaphylaxis, history of allergic reaction(s), known allergy to one of the drugs or excipients administered as part of this study. Mild allergies without angio-edema or treatment need can be acceptable if deemed not of clinical significance (including allergy to animals or mild seasonal hay fever).\n10. Any other diseases, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.",{"count":409,"type":19},32,[280],"VARTUTRACE is a first-in-human PET\u002FCT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS).\n\nOncofetal CS are tumor-specific carbohydrate motifs present in proteoglycans and identified by VAR2 Pharmaceuticals as expressed during fetal development. Oncofetal CS reappears in the vast majority of cancers while remaining largely absent from normal tissues.\n\nVAR2 Pharmaceuticals recently developed antibodies specific for oncofetal CS. VARTUTRACE uses two of these as radiolabeled antibody fragments to study biodistribution, tumor accumulation, pharmacodynamics and clearance pathways in a diverse patient population.",[413,414,415,115,416,417,418,419,420,421,422,423,31,424],"Solid Tumor","Colon Carcinoma","Rectal Carcinoma","Chondrosarcoma","Lung Carcinoma","Head and Neck Squamous Cell Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Pancreas Carcinoma","Bladder Carcinoma","Glioblastoma","Breast Cancer",[426,427,428],"Basket-trial","Oncology","Solid tumors","2025-12-19",{"date":431,"type":45},"2025-12-29",{"date":433,"type":45},"2024-12-10",{"date":435,"type":19},"2026-09",{"name":437,"class":52},"Var2 Pharmaceuticals",{"id":439,"slug":4,"hasResults":10,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":10,"sex":15,"minAge":188,"maxAge":387,"enrollmentInfo":444,"targetDuration":4,"studyType":20,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":455,"locationsCount":4},"100608717","NCT07205185","A Multicenter, Single-arm, Prospective Phase II Clinical Study of Epalrotokewali Combined With Eribulin, Anlotinib, and Radiotherapy for the Treatment of Patients With Advanced Soft Tissue Sarcoma.","A Multicenter, Single-arm, Prospective Phase II Clinical Study of Epalrotokewali Monotherapy Combined With Eribulin, Anlotinib, and Radiotherapy for the Treatment of Patients With Advanced Soft Tissue Sarcoma.","Inclusion Criteria:\n\n* Signed informed consent form;\n* Subjects aged 14-75 years;\n* Patients with histologically or cytologically confirmed advanced soft tissue sarcoma (STS);\n* Patients with STS who have failed first-line or higher treatment;\n* At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1);\n* ECOG performance status (PS) score of 0-1;\n* Adequate organ and bone marrow function, with laboratory tests meeting the following criteria within 7 days prior to the first dose of study drug (without having received any blood components, hematopoietic growth factors, albumin, or other medications considered corrective therapy by the investigator within 14 days prior to testing):\n\n  i. Hematology: Hemoglobin (Hb) ≥90 g\u002FL, absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count (PLT) ≥90×10⁹\u002FL.\n\nii. Biochemistry: Serum creatinine (Cr) ≤1.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN for subjects without liver metastases, and ALT and AST ≤5.0×ULN for subjects with liver metastases; serum albumin (ALB) ≥25 g\u002FL.\n\niii. Coagulation function: International normalized ratio (INR) ≤1.5×ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN (for subjects receiving prophylactic anticoagulation therapy, the investigator should assess that INR and APTT are within safe and effective therapeutic ranges);\n\n* Women of childbearing potential must use reliable contraception from screening until 3 months after discontinuation of trial medication, and have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. Men must agree to use appropriate contraception or have undergone surgical sterilization from screening until 3 months after discontinuation of trial medication;\n* Expected survival time ≥12 weeks.\n\nExclusion Criteria:\n\n* History of allergy to QL1706 or any of its components, or contraindication to its treatment;\n* Prior administration of QL1706 or eribulin;\n* Specific pathological subtypes, such as Ewing sarcoma, non-poly-morphic rhabdomyosarcoma, or gastrointestinal stromal tumor (GIST);\n* Resistance or intolerance to anlotinib, eribulin, radiotherapy, or any other contraindications to these treatments;\n* Use of any other investigational drug within 4 weeks prior to screening or participation in another clinical trial;\n* Diagnosis of immunodeficiency or ongoing systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first trial treatment;\n* Known history of active Mycobacterium tuberculosis (TB) infection;\n* Known history of human immunodeficiency virus (HIV) infection;\n* Active brain metastases or meningeal metastases;\n* Uncontrolled hypertension (systolic blood pressure \\[SBP\\] ≥140 mmHg or diastolic blood pressure \\[DBP\\] \\>90 mmHg despite optimal medical therapy);\n* Severe cardiovascular disease: myocardial ischemia of grade II or higher, myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450 ms in males or ≥470 ms in females); NYHA class III-IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% as assessed by echocardiography;\n* Respiratory syndrome (dyspnea of CTCAE grade ≥2), or uncontrolled serous cavity effusion (including pleural effusion, ascites, or pericardial effusion);\n* Active hepatitis C and\u002For hepatitis B infection (hepatitis B: HBsAg-positive with HBV DNA ≥500 IU\u002FmL; hepatitis C: HCV RNA-positive);\n* Major surgical procedure, severe traumatic injury, fracture, or ulcer within 4 weeks prior to randomization;\n* History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), vascular thrombosis associated with antiphospholipid syndrome (APS), Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome (GBS), multiple sclerosis (MS), vasculitis, or glomerulonephritis;\n* Medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results, prevent the subject from completing the study, or other conditions deemed unsuitable for study participation by the investigator.",{"count":445,"type":19},46,[93],"This study intends to enroll patients with advanced soft tissue sarcoma, employing immunotherapy combined with eribulin, anlotinib, and radiotherapy as subsequent-line treatment to preliminarily explore its efficacy and safety. QL1706, a dual-targeting agent against PD-1 and CTLA-4, has been approved by the National Medical Products Administration (NMPA) of China for the second-line treatment of cervical cancer.",[31],"2025-09-25",{"date":451,"type":45},"2025-10-03",{"date":453,"type":19},"2025-10-01",{"date":100,"type":19},{"name":456,"class":83},"Fudan University",{"id":458,"slug":4,"hasResults":10,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":20,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":53},"100584453","NCT06889532","SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery","SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Controlled Study to Evaluate the Wound Management in Sarcoma Surgery","SAVE","Inclusion Criteria:\n\nPatients must be over 18 years old.\n\n* Patients of any gender and background can be included.\n* The largest tumor diameter on imaging must be at least 5 cm. Preoperative imaging is required to assess tumor dimensions.\n* Sarcomas must be located in the lower extremity or groin.\n* Cases must be discussed preoperatively at an interdisciplinary tumor board.\n* Patients must provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Tumors smaller than 5 cm and superficial masses.\n* Patients with local recurrences or prior wound healing complications in the surgical area.\n* Patients with ulcerating or infected tumors, or those requiring emergency surgery.\n* Other Soft Tissue Tumors such as Kaposi sarcoma.\n* for whom direct closure is not possible during the initial surgery due to the extent of resection.",{"count":465,"type":19},100,[65],"The aim of this study is to evaluate local complications following sarcoma resection in the groin and thigh regions with regard to the planned wound closure method. To this end, temporary soft tissue coverage using a vacuum-assisted closure (VAC) system and delayed secondary closure with wound sutures and drainage placement will be compared to primary closure with drainage in terms of wound infections, revisions, and seroma formation.",[31],[470,471,472,71,73],"randomized","controlled","vacuum therapy","2025-03-16",{"date":475,"type":45},"2025-03-21",{"date":477,"type":45},"2024-11-01",{"date":479,"type":19},"2025-12-31",{"name":481,"class":83},"Universitätsklinikum Hamburg-Eppendorf",{"id":483,"slug":4,"hasResults":10,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":488,"targetDuration":4,"studyType":20,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":498,"locationsCount":381},"100581305","NCT06848582","Umbilical Cord Blood NK Cell Therapy for High-Risk Pediatric Soft Tissue Sarcoma: Efficacy and Safety Study","A Single-Arm, Non-Blind Clinical Study on the Efficacy and Safety of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-Risk, Recurrent\u002FRefractory Soft Tissue Sarcoma","Inclusion Criteria:\n\nTo be eligible for the study, participants must meet all of the following criteria:\n\n1. Give informed consent and sign a written informed consent form.\n2. Age ≤ 18 years, no gender limitation.\n3. Karnofsky (≥16 years) or Lansky (\\\u003C16 years) (Appendix 2) performance status score of at least 50 (Appendix 2).\n4. Diagnosis of high-risk and relapsed\u002Frefractory pediatric soft tissue sarcoma, confirmed by clinical criteria, and who have undergone prior comprehensive treatment (surgery, chemotherapy, radiation, and\u002For stem cell transplantation).\n5. Estimated survival time of at least 12 weeks.\n6. Complete recovery from all acute toxicities of prior anti-cancer chemotherapy, such as bone marrow suppression with recovery to grade I.\n7. Myelosuppressive chemotherapy: at least 21 days after the last myelosuppressive chemotherapy (42 days if prior use of nitrosourea).\n8. Experimental drugs or anti-cancer therapies other than chemotherapy: not used within 28 days prior to the planned start of NK cell immunotherapy. Must be fully recovered from the clinical significant toxicity of the therapy.\n9. Hematopoietic growth factors: at least 14 days after the last administration of long-acting growth factor or 3 days after the last administration of short-acting growth factor.\n10. X-ray therapy (XRT): at least 14 days after local palliative XRT (small field mouth) or at least 42 days after other substantive bone marrow (BM) irradiation, including prior radioactive iodine-131 meta-iodobenzylguanidine (131I-MIBG) treatment.\n11. Stem cell transplantation without whole-body irradiation (TBI): no evidence of active graft versus host disease (GvHD), and at least 56 days after transplantation or stem cell transplantation.\n12. Laboratory tests during the screening period must meet the following conditions:\n\n    Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL (ANC ≥ 0.5 × 10\\^9\u002FL if bone marrow involvement).\n\n    Platelet count (PLT) ≥ 75 × 10\\^9\u002FL (PLT ≥ 20 × 10\\^9\u002FL if bone marrow involvement).\n\n    Bilirubin ≤ 1.5 times the upper limit of normal (ULN). Creatinine ≤ 1.5 times the ULN (calculated according to the standard Cockcroft-Gault formula).\n\n    ALT\u002FAST ≤ 3 times the ULN (can be relaxed to 5 times the ULN if liver metastasis is present).\n13. Ability to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during the study. For pediatric or adolescent participants, the parent\u002Fguardian must be able to understand, consent, and sign the study informed consent form (ICF) and applicable child consent form before initiating any protocol-related procedures. The participant will be able to express their consent (where applicable) under the consent of the parent\u002Fguardian.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are not eligible for the study:\n\n1. Presence of symptomatic brain metastasis (patients with brain metastasis treated and symptomatically stable for at least 2 months before enrollment are eligible, but must be confirmed to have no cerebral hemorrhage symptoms by cranial brain MRI, CT, or venous contrast).\n2. History of or current cardiovascular disease, including ≥ II-grade myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women), or ≥ III-IV-grade heart failure according to the NYHA standard (Appendix 3) or left ventricular ejection fraction (LVEF) \\\u003C 50% according to echocardiography.\n3. History of or current interstitial lung disease.\n4. Coagulation function abnormality (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds or APTT \\> 1.5 ULN), with bleeding tendency or receiving anticoagulation or thrombolytic therapy.\n5. Any venous or arterial thromboembolic event within 12 months prior to enrollment, including cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n6. Known hereditary or acquired bleeding and thrombotic tendency (e.g., hemophiliacs, coagulation dysfunction, thrombocytopenia, splenomegaly).\n7. Long-term, untreated wounds or fractures (excluding pathologic fractures caused by tumor).\n8. Major surgery or severe traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment.\n9. Factors that significantly affect the absorption of oral drugs, such as difficulty swallowing, chronic diarrhea, and intestinal obstruction.\n10. History of abdominal fistula, gastrointestinal perforation, or peritonitis within the past 6 months.\n11. Urinary routine showing ≥ ++ proteinuria, and confirmed 24-hour urine protein ≥ 1.0 g.\n12. Presence of symptomatic serous cavity effusion requiring treatment (including pleural effusion, ascites, pericardial effusion); note: asymptomatic serous cavity effusion can be enrolled, symptomatic serous cavity effusion can be enrolled after active symptomatic treatment (not using anti-cancer drugs for serous cavity effusion treatment), and eligible for enrollment according to the judgment of the researcher.\n13. Active infection requiring anti-microbial therapy (e.g., requiring the use of antibacterial drugs, antiviral drugs, but not including chronic hepatitis B anti-hepatitis B treatment, anti-fungal drug treatment).\n14. History of substance abuse of psychiatric drugs and inability to quit or with psychiatric disorders.\n15. Participation in other anti-tumor drug clinical trials within the past 4 weeks.\n16. Receiving systemic hormone treatment or other forms of immunosuppressive treatment within 2 weeks prior to the first dose of the study drug.\n17. History of active autoimmune disease requiring systemic treatment (e.g., using disease-modifying drugs, corticosteroids, or immunosuppressive agents) within the past 2 years; note: alternative treatment (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not considered systemic treatment.\n18. Contraindications for IL-2 use.\n19. Active infection requiring systemic venous treatment.\n20. Administration of live vaccines within 1 month prior to the first use of the study drug; live vaccines against seasonal influenza, injectable inactivated virus vaccines are allowed, but nasal administration of live attenuated influenza vaccines is not allowed.\n21. Prior or concurrent other untreated malignant tumors, excluding cured superficial basal cell carcinoma, cervical in situ carcinoma, and superficial bladder carcinoma.\n22. Other conditions judged by the researcher to potentially affect the conduct of the clinical research and the determination of research results.\n23. Viral screening during the screening period showing any of the following:\n\n    HBsAg positive and HBV DNA above the normal upper limit. Anti-HCV positive and HCV RNA positive. HIV positive.\n24. Prior allogeneic tissue\u002Forgane transplantation.\n25. Poor compliance, unable to cooperate with clinical research.",{"count":63,"type":19},[65],"This is a single-arm, open-label, non-blind, phase I\u002FII clinical trial evaluating the safety and efficacy of umbilical cord blood natural killer (NK) cell in children with high-risk and relapsed\u002Frefractory soft tissue sarcoma (STS).\n\nObjective:\n\nAssess the safety and efficacy of NK cell in high-risk and relapsed\u002Frefractory STS patients.\n\nObserve the pharmacokinetics and pharmacodynamics of NK cells in these patients.\n\nStudy Design:\n\nSingle-arm, open-label, non-blind design. 40 patients with high-risk and relapsed\u002Frefractory STS will receive the NK cell combined with other treatment .\n\nThe treatment regimen involves 8 doses of NK cells injected at specific time points over 3 months, followed by a 3-year follow-up period.",[31],"2025-02-26",{"date":494,"type":45},"2025-02-27",{"date":477,"type":45},{"date":497,"type":19},"2028-02-01",{"name":124,"class":83},{"id":500,"slug":4,"hasResults":10,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":505,"targetDuration":507,"studyType":302,"phases":4,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":53},"100575626","NCT06774729","Development of a Radiomics Model With MR to Predict the Occurence of a Infiltration of Muscoskeletal Tumor","Development of a Radiomics Model With 3T Multiparametric MR to Predict the Occurence of a Perilesional Infiltration of Muscoskeletal Tumor During the Pre- Surgery Planning","Inclusion Criteria:\n\n* Age over 18\n* suspect of soft tissue sarcoma with a indication for surgical treatment\n* suspect of bone cancer tumor with a indication for surgical treatment\n* To give informed consent\n\nExclusion Criteria:\n\n* simultaneous cancer or history of cancer in the last 5 years\n* acute or chronic serious conditions that could\n* contraindication to conduct a Contrast-enhanced magnetic resonance imaging (MRI) such as:\n\n  * renal failure without dialysis\n  * history of allergy to a paramagnetic contrast agent\n  * claustrophobia\n  * symptomatic epilepsy or history of epilepsy\n  * cardiac pacemaker\n  * infusion pump, prosthesis or any implant not compatible with MRI\n  * pregnancy",{"count":506,"type":19},122,"2 Years","The goal of this observational study is to evaluate the feasibility and clinical utility of radiomics to diagnose peri-lesion tumour infiltration of tumours in participants with a suspect of Bone Cancer Tumor or Soft Tissue Sarcoma (STS).\n\nThe main questions it aims to answer are:\n\n* is radiomics able to identify the ratio of participants truly diagnosed as positive to all those who had positive test results?\n* is radiomics able to identify the likelihood that a participant who has a negative test result indeed does not have the disease?\n\nParticipants eligible for this study will get a MRI as part of their regular medical care. The only difference is that their data will be recorded and anonymously analyzed.",[31,510],"Bone Cancer Tumor","2025-01-09",{"date":513,"type":45},"2025-01-14",{"date":515,"type":19},"2025-03",{"date":517,"type":19},"2028-10",{"name":519,"class":83},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":521,"slug":4,"hasResults":10,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":20,"phases":529,"briefSummary":530,"conditions":531,"keywords":536,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":53},"100573637","NCT06748872","EPITOME-1015-I: a Study to Investigate the Safety and Tolerability of MDG1015 in Patients with Epithelial Ovarian Cancer, Gastroesophageal Adenocarcinoma, Round Cell Liposarcoma And\u002For Synovial Sarcoma","EPITOME-1015-I: a Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of a Third Generation TCR-T Therapy, MDG1015, in Epithelial Ovarian Carcinoma, Gastroesophageal (Junction) Adenocarcinoma, Myxoid (Round Cell) Liposarcoma And\u002For Synovial Sarcoma Subjects with Advanced Disease Expressing NY-ESO-1 And\u002For LAGE-1a","EPITOME-1015-I","Inclusion Criteria:\n\n1. Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4\n2. Subject must have a confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer Gastric or esophageal (junction) adenocarcinoma Myxoid (round cell) liposarcoma Synovial sarcoma\n3. Subject's must have tested positive for HLA-A\\*02:01 genotype by a Sponsor designated central laboratory\n4. Subject's tumor must have tested positive for NY-ESO-1 and\u002For LAGE-1a mRNA expression by a Sponsor designated central laboratory Both ≤1 year old archival tissue or fresh biopsy are allowed\n5. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit\n6. Subjects must have\n\n   1. measurable disease\n   2. Life expectancy ≥ 3 months per Investigator's opinion\n\n8\\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 9. Adequate vital organ function 10. Adequate bone marrow function 11. Adequate coagulation profile 12. Toxicities from prior\u002Fongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0 or Subject's baseline excluding alopecia 14. Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1 15. Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)\n\nExclusion Criteria:\n\n1. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined\n2. HLA-A\\*02:02 or HLA-A\\*02:03 genotype\n3. Pregnant or lactating women\n4. Viral serology:\n\n   1. Known infection with HIV-1\u002F2, CMV (CMV required only for U.S. sites) or HTLV-1\u002F2,\n   2. Active infection with HBV or HCV\n   3. Positive test for Mycoplasma or Treponema Pallidum\n5. Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC (patients receiving prophylactic antibiotics are eligible)\n6. Inadequate venous access for or contraindications to leukapheresis\n7. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients, LDC agents, rasburicase, methylprednisolone or tocilizumab.\n8. Untreated CNS metastases or active CNS metastases (progressing or requiring corticosteroids for symptoms control) and leptomeningeal disease\n9. Unstable\u002Factive ulcer, varices, or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding\n10. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. The following are exempt from the 1-year limit:\n\n    1. non-melanoma skin cancer\n    2. curatively treated localized prostate cancer\n    3. carcinoma in situ (e.g. cervix, bladder, breast)\n11. NYHA Class ≥ II, heart failure, unstable angina, a history of recent (≤ 6 months) arrythmias, myocardial infarction or sustained (\\> 30 seconds) ventricular tachyarrhythmias\n12. Subjects who are dependent on dialysis\n13. Subjects with a history of pulmonary embolism or deep vein thrombosis that cannot safely withhold anti-coagulant therapy from leukapheresis until 7 days after administration of MDG1015 as determined by the Investigator\n14. Active autoimmune disease requiring systemic therapy except for adequately controlled Type 1 diabetes mellitus, autoimmune hypothyroidism or Grave's disease\n15. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant\n\n    Specific to GAC\u002FGEJ Subjects:\n16. Positive history of esophageal or gastric resection that the Investigator considers is at increased risk of bleeding or perforation",{"count":528,"type":19},55,[22],"MDG1015 is a third generation TCR-T therapy product targeting NY-ESO-1\u002FLAGE-1a armored and enhanced by the PD1-41BB costimulatory switch protein (CSP). The study purpose is to establish the safety, tolerability and preliminary efficacy of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and\u002For synovial sarcoma that expresses NY-ESO-1 and\u002For LAGE-1a.\n\nThe main questions this clinical trial aims to answer are:\n\nCan this TCR-T therapy MDG1015 be given to patients safely? What is the optimal dose of the TCR-T therapy MDG1015? If and what side effects do participants experience after receiving the TCR-T therapy MDG1015? Do participants experience a potential disease response after receiving the TCR-T therapy MDG1015?\n\nParticipants will:\n\nReceive (in most cases) 1 single infusion of MDG1015 at a pre-defined dose level and will be followed up regularly up to 1 year. After one year, participants will enter the long term follow-up part up to 15 years after being treated. Any side effects and\u002For potential disease response will be documented during this period.",[532,533,31,534,535],"Epithelial Ovarian Cancer","Gastro-esophageal Junction Cancer","Myxoid Liposarcoma","Synovial Sarcoma",[537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552],"TCR-T Therapy","dose escalation","Third Generation TCR-T Therapy","autologous, patient derived CD8+ T cells","single arm","open label","phase I","BOIN design","NY-ESO-1","LAGE-1a","solid tumors","PD1-41BB","Costimulatory Switch Protein","Armoring","Enhancement","First-in-human","2024-12-23",{"date":555,"type":45},"2024-12-27",{"date":557,"type":19},"2025-07-01",{"date":559,"type":19},"2042-08-01",{"name":561,"class":52},"Medigene AG",{"id":563,"slug":4,"hasResults":10,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":20,"phases":570,"briefSummary":571,"conditions":572,"keywords":579,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":604},"100502647","NCT05824975","A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)","An Open-label, Multicenter, Dose Escalation and Expansion Phase 1\u002F2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)","Key Inclusion Criteria:\n\n* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n* Has adequate organ and marrow function as defined in protocol.\n* Measurable disease as per RECIST v1.1.\n* ECOG performance status 0-1.\n* Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.\n* HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection\u002Fdisease as defined in protocol.\n\nKey Exclusion Criteria:\n\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* An active second malignancy.\n* Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has active tuberculosis or has a known history of active tuberculosis.\n* Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.\n* History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Previous immunotherapies related to mode of action of GI-102.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.\n* Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.\n* Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy.\n* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.\n* Known hypersensitivity to any of the components of the drug products and\u002For excipients of GI-102.\n\nOther protocol defined inclusion exclusion criteria may apply",{"count":569,"type":19},358,[22,93],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and\u002For metastatic solid tumors.",[573,574,31,575,576,30,577,140,578],"Advanced Solid Tumor","Metastatic Solid Tumor","Platinum-resistant Ovarian Cancer (PROC)","Hepatocellular Carcinoma (HCC)","HER2 Negative Breast Cancer","Renal Cell Carcinoma (RCC)",[580,581,339,582,583,584,585,586,587,588,589,590,591,592,593,594],"GI-102","CD80-IgG4 Fc-IL2 variant","IL-2","Interleukin-2","bispecific protein","immunocytokine","CD80","CTLA-4","Pembrolizumab","T-DXd","Trastuzumab deruxtecan","Doxorubicin","Paclitaxel","Bevacizumab","Eribulin","2024-11-21",{"date":597,"type":45},"2024-11-25",{"date":599,"type":45},"2023-05-30",{"date":601,"type":19},"2027-04-24",{"name":603,"class":52},"GI Innovation, Inc.",11,{"id":606,"slug":4,"hasResults":10,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":20,"phases":613,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":4},"100569848","NCT06699576","ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.","ARTEMIS-103: a Phase 1b, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination with Other Anti-cancer Agents in Patients with Bone and Soft Tissue Sarcoma.","Inclusion Criteria:\n\n* At least age of 18 years at screening;\n* Histologically or cytologically confirmed, locally advanced or metastatic osteosarcoma and soft tissue sarcoma\n\n  1. Cohort1: Dose escalation part will enroll advanced soft tissue sarcoma for which standard treatment has proven ineffective or unavailable or intolerable. Dose expansion part will enroll patients who have not received prior treatment for advanced\u002Fmetastatic disease.\n  2. Cohort2: Advanced osteosarcoma patients for which standard treatment has proven ineffective or unavailable or intolerable.\n* least one extra-cranial measurable lesion according to RECIST 1\n* Agree to provide fresh or archival tumor tissue\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1\n* Life expectancy \\>= 12 weeks\n* Agree to use medically accepted methods of contraception\n* Men or women should be using adequate contraceptive measures throughout the study;\n* Females subjects must not be pregnant at screening or have evidence of non-childbearing potential\n* Signed and dated Informed Consent Form\n\nExclusion Criteria:\n\n* treatment with any of the following:\n\n  1. Previous or current treatment with B7-H3 targeted therapy\n  2. Previous or current treatment with TOP1i related treatment\n  3. Previous or current treatment with PD-L1 inhibitor (Cohort2 )\n  4. Intolerable for any Anlotinib(Cohort 1a\u002F1c), Anthracyclines (Cohort 1b\u002F1c) and PD-L1 inhibitor (Cohort2 )\n  5. Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093\n  6. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093\n  7. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093\n  8. Major surgery within 4 weeks prior to the first scheduled dose of HS-20093\n* Subjects with previous or concurrent malignancies\n* Inadequate bone marrow reserve or organ dysfunction\n* Evidence of cardiovascular risk\n* Evidence of current severe or uncontrolled systemic diseases\n* Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093\n* Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093\n* Subjects with current infectious diseases\n* History of neuropathy or mental disorders\n* Pregnant or lactating female\n* History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments",{"count":612,"type":19},448,[22],"HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on bone and soft tissue sarcoma. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced bone and soft tissue sarcoma.",[115,31],[617,115,169,618,619],"Phase 1b","HS-20093","B7-H3","2024-11-19",{"date":595,"type":45},{"date":623,"type":19},"2024-12-20",{"date":625,"type":19},"2028-12-30",{"name":627,"class":52},"Hansoh BioMedical R&D Company",{"id":629,"slug":4,"hasResults":10,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":387,"enrollmentInfo":634,"targetDuration":4,"studyType":20,"phases":636,"briefSummary":637,"conditions":638,"keywords":640,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":53},"100569444","NCT06694324","First-line Treatment of Advanced\u002Funresectable DDLPS","Liposomal Doxorubicin Hydrochloride and Apatinib in Combination with Camrelizumab for the First-line Treatment of Advanced\u002Funresectable Dedifferentiated Liposarcoma","Inclusion Criteria:\n\n1. Age 18-75 years, male or female;\n2. Histologically confirmed dedifferentiated liposarcoma;\n3. metastatic stage not having received systemic therapy;\n4. no brain metastases;\n5. ECOG PS: 0\\~1 points;\n6. normal function of major organs, meeting the following requirements (within 7 days prior to initiation of study treatment): 1)Left ventricular ejection fraction (LVEF) ≥50%; 2)Normal electrocardiogram; 3)Hemoglobin \\[HB\\] ≥ 90 g\u002FL; 4)Absolute neutrophil count \\[ANC\\] ≥1.5×109\u002FL; 5) Platelet \\[PLT\\] ≥100×109\u002FL; 6)Serum total bilirubin \\[TBIL\\] ≤1.5 times the upper limit of normal (ULN); 7) alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\] \\\u003C2.5 × ULN; if there are liver metastases, ALT and AST ≤5 × ULN; 8) Serum creatinine \\[Cr\\] ≤ 1 × ULN or endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n7. women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use an appropriate method of contraception for the duration of the observation period and for 8 weeks after the final administration of study drug; in the case of males, they should be surgically sterilized or agree to use an appropriate method of contraception for the duration of the observation period and for 8 weeks after the final administration of study drug;\n8. expected to have good compliance and be able to follow up on efficacy and adverse effects as required by the protocol;\n9. sign an informed consent form.\n\nExclusion Criteria:\n\n1. patients with recurrence within six months of postoperative adjuvant therapy;\n2. previous adjuvant or neoadjuvant phase with cumulative dose of doxorubicin, liposomal doxorubicin, or other anthracyclines ≥ 240 mg\u002Fm2;\n3. Use of PD-1 or PD-L1 inhibitors in prior adjuvant or neoadjuvant phase;\n4. patients with prior adjuvant or neoadjuvant phase use of apatinib mesylate and patients with prior treatment with vascular endothelial growth inhibitor-targeted agents such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, pazopanib, regorafenib, and erlotinib.\n5. Other active malignancies within 5 years or concurrently;\n6. central nervous system involvement;\n7. clinical symptoms or diseases of the heart that are not well controlled, such as (1) cardiac insufficiency of grade II or higher according to the New York Heart Association (NYHA) criteria or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction within 1 year prior to the start of study treatment; (4) clinically significant supraventricular or ventricular arrhythmia Need for treatment or intervention: (5) QTc \\>450 ms (men); QTc \\>470 ms (women) (QTc intervals are calculated using the Fridericia formula; if the QTc is abnormal, three consecutive measurements may be taken at approximately 2-minute intervals and averaged);\n8. patients with signs or history of bleeding, regardless of severity; any bleeding or bleeding event CTCAE grade 3 within 4 weeks prior to enrollment, unhealed wounds, ulcers, or fractures\n9. those with hypertension that cannot be reduced to the normal range (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) with antihypertensive medication (based on the average of BP readings obtained from ≥2 measurements) are permitted to achieve the above parameters with the use of antihypertensive therapy;\n10. patients with severe hepatic or renal insufficiency (grade 4);\n11. poorly controlled diabetes mellitus (FBG) \\> 10 mmol\u002FL);\n12. Patients with active ulcers, intestinal perforation, intestinal obstruction;\n13. Routine urinalysis showing urinary protein++, confirming 24-hour urine protein quantification \\>1.0g;\n14. Presence of active autoimmune disease or history of autoimmune disease with possible relapse;\n15. Uncontrolled infection or unexplained fever \\>38.5°C at screening;\n16. a known history of severe allergy to the study drug;\n17. other patients deemed unsuitable for inclusion by the treating physician.",{"count":635,"type":19},49,[93],"Evaluating the efficacy and safety of liposomal doxorubicin hydrochloride and apatinib in combination with camrelizumab for the first-line treatment of advanced\u002Funresectable dedifferentiated liposarcoma",[639,31],"Dedifferentiated Liposarcoma",[641,642,643,644],"liposomal doxorubicin","apatinib","Camrelizumab","first line treatment","2024-11-17",{"date":620,"type":45},{"date":648,"type":19},"2024-12-01",{"date":650,"type":19},"2026-12-01",{"name":456,"class":83},""]