[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bile-duct-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bile-duct-cancer":819},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,61,141,169,196,237,249,277,312,336,362,456,477,511,534,574,602,630,653,686,716,745,769,796],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100053405",false,"NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","ALL","18 Years","99 Years",{"count":18,"type":19},29,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[26,27,28,29,30,31,32,33,34],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[36,37,38,39,40,41,42,43,44,45,46,47],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor","RECRUITING","2026-07-10",{"date":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":52},"2021-12-07",{"date":56,"type":19},"2027-06",{"name":58,"class":59},"University of Florida","OTHER",1,{"id":62,"slug":4,"hasResults":10,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":14,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":72,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":121,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"19 Years","110 Years",{"count":71,"type":19},999999,"80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[76,77,78,79,80,81,82,83,84,26,85,86,87,88,89,90,91,92,93,94,95,34,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,28,112,113,114,115,116,30,117,118,29,119,120],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Endometrial Cancer","Vaginal Cancer","Plasma Cell Dyscrasia","Healthy Control",[76,77,122,123,124,125,126,127,128,129,28,130,119,120],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","2026-06-25",{"date":133,"type":52},"2026-06-29",{"date":135,"type":52},"2013-11-01",{"date":137,"type":19},"2099-12",{"name":139,"class":59},"University of Nebraska",42,{"id":142,"slug":4,"hasResults":10,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":10,"sex":14,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":4,"leadSponsor":166,"locationsCount":60},"100202701","NCT01915225","Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer","Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors","* INCLUSION CRITERIA:\n* Participants must be 2 years of age or older. Note: Participants greater than or equal to 2 and \\\u003C 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the biospecimen sampling (e.g., blood, urine, ascites, bile, or \\[clinically indicated\\] resected tumor tissue) does not add risk to the clinically indicated procedures.\n* Participants who have premalignant, primary, or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological\u002Fcytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment, and\u002For follow-up.\n* Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.\n* Participants should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery.\n* Participants must be planning to undergo surgery or biopsy as part of their normal treatment plan.\n* Ability of participant, parent\u002Fguardian or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone.","2 Years",{"count":149,"type":19},1800,"Background:\n\n\\- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).\n\nObjectives:\n\n\\- To collect tissue samples for use in studying new ways to treat tumors.\n\nEligibility:\n\n* Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.\n* Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.\n\nDesign:\n\n* Before their procedure, participants will have a small blood sample taken.\n* Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.\n* For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.\n* Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.",[152,153,154,26,155],"Colorectal Neoplasms","Gastric Neoplasms","Cholangiocarcinoma","Pancreas Cancer",[157,158,159,160],"Tissue Procurement","Surgery","Metastasectomy","Natural History","2026-06-17",{"date":163,"type":52},"2026-06-18",{"date":165,"type":52},"2013-07-21",{"name":167,"class":168},"National Cancer Institute (NCI)","NIH",{"id":170,"slug":4,"hasResults":10,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":10,"sex":14,"minAge":175,"maxAge":72,"enrollmentInfo":176,"targetDuration":4,"studyType":20,"phases":178,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":60},"100641453","NCT07653594","TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE)","TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE): A Single Arm Pilot Study","Inclusion Criteria:\n\n* Age 50 to 80\n* Able to speak and understand English\n* Scheduled to undergo a surgery meeting the following criteria: (1) traditional open surgery (not laparoscopic or robotic) via laparotomy (midline or subcostal incisions), (2) length of surgery \\>3 hours, and (3) curative-intent surgical resection of a cancer in the stomach, pancreas, bile ducts, liver, or peritoneal surfaces\n* Participant reports pain intensity of 4\u002F10 or above to study staff on day 1 post-surgery or any other day post-surgery through discharge\n\nExclusion Criteria:\n\n* Significant visual impairment that has not been corrected\n* Significant hearing impairment that has not been corrected\n* Significant cognitive impairment that would prevent participant from participating in the study","50 Years",{"count":177,"type":19},20,[179],"NA","Participants may take part in this study if they are scheduled to undergo a surgery that meets the following: (1) traditional open surgery via laparotomy, (2) length of surgery \\>3 hours, and (3) curative-intent surgical resection of a cancer in the stomach, pancreas, bile ducts, liver, or peritoneal surfaces. The purpose of this study is (1) to evaluate the feasibility of collecting blood samples prior to surgery, post-surgery and pre- music-assisted relaxation and imagery (MARI) intervention, and immediately post-MARI intervention and (2) to identify gene expression changes associated with MARI and explore their relationship with immediate changes in pain intensity. Participants will be in this study for the duration of their hospital admission for surgery.",[158,182,155,26,88,183],"Stomach Cancer","Peritoneal Cancer",[185,186],"Music therapy","Music-assisted relaxation and imagery","NOT_YET_RECRUITING","2026-06-15",{"date":161,"type":52},{"date":191,"type":19},"2027-01",{"date":193,"type":19},"2027-12",{"name":195,"class":59},"Case Comprehensive Cancer Center",{"id":197,"slug":4,"hasResults":10,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":20,"phases":205,"briefSummary":206,"conditions":207,"keywords":218,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":60},"100461298","NCT05286814","PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n\nInclusion Criteria- All Cohorts\n\n* Participants must have a documented diagnosis of one of the following cancers:\n\n  * Metastatic colorectal cancer (mCRC)\n  * Intrahepatic cholangiocarcinoma (ICC)\n  * Adrenocortical carcinoma (ACC) with liver dominant disease\n* Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:\n\n  * mCRC: FOLFOX or FOLFIRI\n  * ICC: GemOx or FOLFOX\n  * ACC: GemOx\n* Age \\>= 18 years.\n* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).\n\nNOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n* All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing.\n* Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C\u002FA\u002FP multiphase) amenable to placement of the HAIP.\n* Participant must sign the informed consent form to participate in this study.\n* HIV-positive participants may be considered for this study only if they have an undetectable viral load.\n* Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n* Participant's liver metastases must not be amenable to resection\u002Fablation to No Evidence of Disease (NED) in one stage.\n\nInclusion Criteria-Metastatic Colorectal Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).\n* Participants must have measurable liver metastatic disease.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nInclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n* Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.\n* Participants must have radiographically measurable disease.\n* Disease must be considered unresectable at the time of preoperative evaluation.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 2,000\u002F mm\\^3\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\>= 75,000\u002F mm\\^3\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 mg\u002Fdl\n  * creatinine \\\u003C= 1.5 mg\u002Fdl\n\nInclusion Criteria-Adrenocortical Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as \"adrenocortical cancer\".\n* Participants must have received at least one line of systemic chemotherapy.\n* Participants must have measurable liver metastatic disease.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 X institutional upper limit of normal\n  * creatinine \\\u003C 2 X institutional upper limit of normal\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria- All Cohorts\n\nParticipants who are receiving any other investigational agents.\n\n* Participants who have previously received rIL-12.\n* Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:\n\n  * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;\n  * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10 mg of prednisone or equivalent per day;\n  * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.\n* History of organ transplant, except for transplants that do not require immunosuppression.\n* History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).\n* Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke \\\u003C 6 months prior to enrollment, myocardial infarction \\\u003C 6 months prior to enrollment, unstable angina, congestive heart failure (\\>= NYHA III) or serious cardiac arrhythmia requiring medication.\n* All conditions associated with significant necrosis of nontumor-bearing tissues.\n* Esophageal or gastroduodenal ulcers \\\u003C 6 months prior to treatment.\n* Active ischemic bowel disease.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.\n* Prior radiation to liver.\n* Participants with active Hepatitis B or C infection.\n* Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).\n* Any condition, including the presence of laboratory abnormalities and\u002For insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n\nExclusion Criteria-Metastatic Colorectal Carcinoma\n\n-Participants with incontrovertible radiographic evidence of disease outside of the colon\u002Frectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.\n* Participants with a history of MSI-high results who need to be treated with check-point inhibitors.\n* Prior treatment with FUDR.\n\nExclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n-Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Prior treatment with FUDR.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n\nExclusion Criteria-Adrenocortical Carcinoma\n\n* Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n* Diagnosis of sclerosing cholangitis.\n* Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.\n* Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.","120 Years",{"count":204,"type":19},70,[23],"Background:\n\nOne way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\\\u003CTAB\\>\n\nObjective:\n\nTo see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers.\n\nEligibility:\n\nPeople aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test (if needed)\n\nTumor biopsy (if needed)\n\nElectrocardiogram\n\nComputed tomography (CT) scans\n\nParticipants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.\n\nAll participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.\n\nParticipants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks.\n\nParticipants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.\n\nParticipants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.",[208,209,210,152,211,154,212,26,213,214,215,216,217],"Metastatic Colorectal Cancer (Mcrc)","Intrahepatic Cholangiocarcinoma (Icc)","Intrahepatic Bile Duct Cancer","Colorectal Cancer","Bile Duct Neoplasms","Adrenocortical Carcinoma (ACC)","Adrenal Cortical Carcinoma","Adrenal Gland Cancer","Adrenal Gland Neoplasms","Adrenal Cortex Neoplasms",[219,220,221,222,223,224,225,226,227,228],"Unresectable Liver Tumor","SMART System","Response Rates","Progression Free Survival (Pfs)","Patient Survival","Overall Survival (Os)","NHS-IL12","Mcrc","Icc","ACC","2026-06-09",{"date":231,"type":52},"2026-06-10",{"date":233,"type":52},"2022-10-24",{"date":235,"type":19},"2028-12-31",{"name":167,"class":168},{"id":238,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":239,"targetDuration":4,"studyType":20,"phases":240,"briefSummary":24,"conditions":241,"keywords":242,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":248,"locationsCount":60},"100439284",{"count":18,"type":19},[22,23],[26,27,28,29,30,31,32,33,34],[36,37,38,39,40,41,42,43,44,45,46,47],"2026-06-04",{"date":245,"type":52},"2026-06-05",{"date":54,"type":52},{"date":56,"type":19},{"name":58,"class":59},{"id":250,"slug":4,"hasResults":10,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":20,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100537211","NCT06274879","Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer","Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer (EBTC) Undergoing Systemic Anti-tumor Therapy: a Phase II, Multi-center, Randomized, and Controlled Study (Ablatio-bilica)","Ablatio","Inclusion criteria\n\n1. Male or female ≥18 years old.\n2. Histologically or cytologically confirmed diagnosis of previously untreated and unresectable\\*, locally advanced and\u002For metastatic extrahepatic biliary tract cholangiocarcinoma with obstructive jaundice (increased serum level of total bilirubin).\n3. ECOG performance status 0 to 2.\n4. Adequate bone marrow function: Neutrophil count ≥1.0 x 109\u002FL, platelet count ≥100 x 109\u002FL.\n5. Adequate renal function in case of cisplatin administration: Estimated Glomerular Filtration Rate (eGFR) ≥60mL\u002Fmin\u002F1.73m2.\n6. Willing and able to provide written informed consent.\n7. Planned initiation of any standard-of-care systemic anti-proliferative therapy against ETB.\n\n   \\*The reason for inoperability needs to be documented and categorized as follows:\n   * Wish of patient.\n   * Locally advanced or vascular invasion = surgically not removable.\n   * Remnant liver is not sufficient.\n   * Anatomic contraindications.\n   * Distant metastasis.\n   * Severe comorbidities.\n   * Other reasons. Exclusion criteria\n\n\u003C!-- -->\n\n1. Solely intrahepatic cholangiocarcinoma or mixed type liver tumors (cholangiocarcinoma with hepatocellular differentiation parts).\n2. Multiple hepatic metastases with significant blockage of one or more liver segments and\u002For less than 50% of liver parenchyma potentially drainable on pre-intervention imaging.\n3. In case of immune-checkpoint-inhibitor (ICI) administration, any autoimmune diseases including inflammatory disorders such as Crohn's disease, ulcerative colitis, Wegener granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease.\n\n   Exceptions:\n\n   \\- Hypothyroidism following Hashimoto thyroiditis stable on hormone replacement.\n\n   \\- Patients with vitiligo.\n\n   \\- Any chronic skin disorders that do not require systemic treatment.\n4. Use of immunosuppressive medication within 3 weeks prior to ICI administration.\n\n   Exceptions:\n\n   \\- Topical or inhaled steroids.\n   * Systemic corticosteroids at physiologic doses not exceeding \\>10mg\u002Fd of prednisone or equivalent.\n5. Prior Self-Expandable Metal Stent (SEMS) placement in the biliary tree.\n6. Biliary obstruction of non-tumoral etiology.\n7. Platelets \\\u003C100 x 109\u002FL or International Normalized Ratio (INR) \\>1.5.\n8. Secondary tumor.\n\n   Exceptions:\n\n   \\- Tumor treated with curative intent without recurrence for more than 5 years.\n   * Non-melanoma skin cancer treated carcinoma in situ without evidence of disease.\n9. Pregnancy or lactation.\n10. Known or suspected non-compliance, drug, or alcohol abuse.\n11. Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the candidate.\n12. Participation in another interventional study within 30 days prior to enrollment.\n13. Previous participation in the current study.\n14. Other diseases like Human Immunodeficiency Virus, Liver cirrhosis Child-Pugh B or C, cardiac pacemaker, history of organ transplantation or condition likely to significantly decrease life expectancy i.e., life expectancy is less than 3 months according to investigator judgement.",{"count":257,"type":19},36,[23],"The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). The main question it aims to answer is whether it is safe to combine systemic anti-tumor therapy with or without ICI with and bRFA.\n\nParticipants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and systemic anti-tumor therapy, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.\n\nResearchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.",[26],[262,263,264,265,266],"Durvalumab + chemotherapy","Radiofrequency ablation","Adverse events","Chemo-immune-checkpoint-inhibitor","Extra hepatic biliary tract cancer","2026-05-21",{"date":269,"type":52},"2026-05-26",{"date":271,"type":52},"2026-05-20",{"date":273,"type":19},"2030-12-30",{"name":275,"class":59},"Insel Gruppe AG, University Hospital Bern",4,{"id":278,"slug":4,"hasResults":10,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":20,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":60},"100595260","NCT07030140","Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline\u002FUnresectable Hilar Cholangiocarcinoma","A Phase II, Single-arm, Prospective Clinical Study of Neoadjuvant Therapy With Tislelizumab Combined With Radiotherapy and Gemcitabine-Platinum Chemotherapy for Borderline Resectable or Unresectable Hilar Cholangiocarcinoma","Inclusion Criteria:\n\n* Age 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma\n* Borderline resectable or unresectable disease based on imaging and MDT evaluation\n* ECOG performance status 0-1\n* Adequate hematologic, hepatic, and renal function\n* No prior anti-tumor therapy for current diagnosis\n* Expected survival ≥ 3 months\n* Signed informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis\n* Prior treatment with immune checkpoint inhibitors\n* Uncontrolled infection or serious medical comorbidities\n* Active autoimmune disease requiring systemic therapy\n* History of organ transplantation or immunodeficiency\n* Pregnancy or lactation","75 Years",{"count":285,"type":19},38,[23],"This is a phase II, single-arm, prospective clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy combining stereotactic body radiotherapy (SBRT), GP chemotherapy (gemcitabine and cisplatin\u002Foxaliplatin), and tislelizumab in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Eligible patients will receive SBRT followed by three cycles of tislelizumab plus GP chemotherapy. Patients with resectable disease after evaluation may undergo surgery and receive postoperative treatment as recommended by the multidisciplinary team. Those who remain unresectable will receive three additional cycles of systemic therapy. The primary endpoint is overall survival (OS); secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, progression-free survival (PFS), local control rate, and treatment-related safety.",[154,289,26],"Hilar Cholangiocarcinoma",[291,292,293,294,295,296,297,298,299,300,301,302],"Borderline Resectable","Unresectable","SBRT","Tislelizumab","Gemcitabine","Cisplatin","Oxaliplatin","Neoadjuvant Therapy","Immunotherapy","Radiation Therapy","PD-1 Inhibitor","Biliary Tract Cancer","2026-04-27",{"date":305,"type":52},"2026-05-01",{"date":307,"type":52},"2025-07-01",{"date":309,"type":19},"2028-01-01",{"name":311,"class":59},"Jinbo Yue",{"id":313,"slug":4,"hasResults":10,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":20,"phases":320,"briefSummary":321,"conditions":322,"keywords":326,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":60},"100489655","NCT05655949","Y-90 With Durvalumab\u002FGem\u002FCis in Intrahepatic Cholangio","A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine\u002FCisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study\n* Male and female participants at least 18 years of age at the time of signing the ICF\n* Histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma; at least one intrahepatic lesion must be present\n* Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria\n* ECOG performance status ≤1\n* Body weight \\>30 kg\n* Must have a life expectancy of at least 12 weeks\n* Participants must have adequate marrow function as defined below:\n\n  * Hemoglobin ≥9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL\n  * Platelet count ≥75 × 109\u002FL\n* Participants must have adequate renal function as defined below:\n\n  * Serum creatinine ≤ 1.5 mg\u002FdL OR\n  * Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance\n* Participants must have adequate hepatic function as defined below:\n\n  * Bilirubin ≤1.5 x ULN\n  * ALT ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN\n  * AST ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN\n  * This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician\n  * No known history of active HBV or HCV infection.\n\n    * Note: Participants with Hepatitis C who have been clinically cured, defined as persistent absence of Hepatitis C RNA detected by polymerase chain reaction (PCR) test in serum 12 weeks after completing antiviral treatment, are eligible for this study\n    * Note: Participants with a history of Hepatitis B infection that are currently on viral suppressive therapy are eligible for enrollment\n* Adequate coagulation studies as demonstrated by prothrombin (PT) and partial thromboplastin (PTT) time within normal limits (\\\u003C\u002F= 1.5 x ULN) in the absence of anticoagulation medication. Participants receiving anticoagulation may be approved by sponsor\n* Participants with known human immunodeficiency virus (HIV) on effective highly-active antiretroviral therapy (HAART) with undetectable viral load within 6 months are eligible for this trial, so long as the following criteria are met:\n\n  * HAART does not interact with or have overlapping toxicities with study medication, per discretion of the treating provider\n  * CD4 count is ≥350 cells\u002FuL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications\n  * Probable long-term survival with HIV if cancer were not present\n  * Stable on a HAART regimen for ≥4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study\n  * HIV is not multi-drug resistant\n  * Taking medication and\u002For receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication\n\nExclusion Criteria:\n\n* Surgically resectable disease at enrollment\n* Histologically or cytologically confirmed diagnosis of primary hepatocellular carcinoma or mixed adenocarcinoma\u002Fhepatocellular carcinoma\n* Received prior systemic chemotherapy and\u002For radiotherapy for intrahepatic cholangiocarcinoma. Prior surgical resection and adjuvant chemotherapy or chemoradiotherapy is allowed if more than 6 months have elapsed since last dose of treatment, and if the tumor is amenable to Y-90 SIRT\n* Prior treatment with anti-PD-1, anti-PD-L, including durvalumab antibody, or any other drug treatment specifically targeting T-cell co-stimulation or checkpoint pathways\n* Any of the following within 6 months of screening:\n\n  * New York Heart Association (NYHA) Class III or IV heart failure\n  * Myocardial infarction, unstable angina pectoris, or symptomatic coronary artery disease\n  * Unstable arrhythmia\n  * Stroke to transient ischemic attack\n* Previous malignancies, except for adequately treated non-melanoma skin cancer, in-situ cancer, or any other cancer from which the subject has been disease-free for at least 3 years\n* Severe chronic obstructive or other pulmonary disease with chronic baseline hypoxemia due to potential for gemcitabine-induced bronchospasm and\u002For durvalumab-induced pneumonitis\n* Major surgery (other than diagnostic) within 4 weeks of study treatment day 1\n* Active, uncontrolled or untreated bacterial, viral, or fungal infection that requires systemic therapy\n* Active, untreated HIV, HBV, or HCV\n* Subjects who have participated in another investigational drug or device study within 4 weeks prior to study registration.\n\nPregnant women are excluded from this study because cisplatin is a class D agent with the potential for teratogenic or abortifacient effects. Because cisplatin is present in breast milk and there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin, breastfeeding should be discontinued prior to entry into the study. Subjects and their sexual partners entered into the study must agree to contraception. The following restrictions apply while the patient is receiving study treatment and for the specified times before and after:\n\n* Female patients of child-bearing potential Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception (Table 2) from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy). Non-sterilised male partners of a female patient of childbearing potential must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female patients should also refrain from breastfeeding throughout this period.\n* Male patients with a female partner of childbearing potential Non-sterilized male patients who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy). However, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male patients should refrain from sperm donation throughout this period.\n\nFemale partners (of childbearing potential) of male patients must also use a highly effective method of contraception throughout this period (Table 2).\n\nFemales of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.\n\nWomen will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n* Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.\n* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n\nHighly effective methods of contraception, defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly are described in Table 2. Note that some contraception methods are not considered highly effective (e.g. male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action \\[excluding Cerazette\u002Fdesogestrel which is considered highly effective\\]; and triphasic combined oral contraceptive pills).\n\n* Copper T intrauterine device\n* Levonorgestrel-releasing intrauterine system (e.g., Mirena®)a\n* Implants: Etonogestrel-releasing implants: e.g. Implanon® or Norplant®\n* Intravaginal: Ethinylestradiol\u002Fetonogestrel-releasing intravaginal devices: e.g. NuvaRing®\n* Injection: Medroxyprogesterone injection: e.g. Depo-Provera®\n* Combined Pill: Normal and low dose combined oral contraceptive pill\n* Patch: Norelgestromin\u002Fethinylestradiol-releasing transdermal system: e.g. Ortho Evra® Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette® is currently the only highly effective progesterone-based\n\n  * Any concomitant disease or condition that could interfere with the conduct of the study, or that would in the option of the investigator pose an unacceptable risk to the subject in the study\n  * Contraindications to Y-90 SIRT per assessment by treating Interventional Radiologist (eg significant vascular drainage of the tumor to the lung that increases the potential for pulmonary toxicity)\n  * Unwillingness or inability to comply with the study protocol\n  * History of allogenic organ transplantation.\n  * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    * Patients with vitiligo or alopecia\n    * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    * Any chronic skin condition that does not require systemic therapy\n    * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n    * Patients with celiac disease controlled by diet alone\n  * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n  * History of active primary immunodeficiency\n  * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice\n  * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n  * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n  * Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.",{"count":319,"type":19},30,[23],"This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery.\n\nThe specific names of the interventions that will be used are:\n\n* Y-90 (a type of radiation microsphere bead)\n* Durvalumab (a type of immunotherapy)\n* Gemcitabine (a type of chemotherapy)\n* Cisplatin (a type of chemotherapy)",[26,154,323,324,325],"Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Metastatic","Metastatic Intrahepatic Cholangiocarcinoma",[26,154,323,324,325],"2026-04-17",{"date":329,"type":52},"2026-04-22",{"date":331,"type":52},"2024-02-13",{"date":333,"type":19},"2027-12-01",{"name":335,"class":59},"Beth Israel Deaconess Medical Center",{"id":337,"slug":4,"hasResults":10,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":202,"enrollmentInfo":342,"targetDuration":4,"studyType":20,"phases":344,"briefSummary":345,"conditions":346,"keywords":349,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":60},"100504526","NCT05849480","A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)","A Phase I\u002FII Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)","* INCLUSION CRITERIA:\n\n  1. Participants must have histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of BTC.\n  2. The maximum tumor size of any individual tumor or metastasis must be \\\u003C= 8 cm.\n  3. Participants should have progressed on standard of care first line systemic treatment or refused standard treatment.\n  4. Participants must have a disease that is not amenable to potentially curative resection or liver transplantation.\n  5. Participants must have evaluable or measurable disease per RECIST 1.1\n  6. ECOG performance status of 0 to 1\n  7. Participants must have adequate organ and marrow function as defined below:\n\n     Absolute neutrophil count\n\n     (ANC) \\>= 1,000\u002FmcL\n\n     Platelets \\>= 100,000\u002FmcL\n\n     Total bilirubin \\\u003C= 2.5 x ULN\n\n     ALT and AST \\\u003C= 5 x ULN.\n\n     Creatinine OR Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl)\n\n     \\\u003C1.5x institution upper limit of normal OR\n\n     \\>= 45 mL\u002Fmin\u002F1.73 m2 for participant with creatinine levels\n\n     \\>= 1.5 X institutional ULN\n  8. Age \\>=18 years.\n  9. Participants must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be \\\u003C= grade 1. Note: participants with thyroid dysfunction caused by prior therapy including the need for chronic therapy are eligible.\n  10. Individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the study entry, for the duration of study treatment and up to 4 months after the last dose of the CDX-1140 or Keytruda(R) (all individuals), 9 months (IOCBP), 6 months (individuals able to father a child) after completion of CAPOX therapy whatever comes later\n  11. Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after study treatment discontinuation.\n  12. HBV-infected participants must be on antivirals and have HBV DNA \\\u003C100 IU\u002FmL. HCV-infected participants can be enrolled if HCV RNA level is undetectable.\n  13. Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Participants who have had standard-of-care anti-cancer therapy or therapy with investigational agents (e.g., chemotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigation agents) or large field radiotherapy within 4 weeks prior to treatment initiation.\n2. Prior therapy with anti- CD40.\n3. Receiving of live vaccines within 30 days prior to the treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist(R)) are live attenuated vaccines and are not allowed.\n4. Major surgery within 4 weeks prior to treatment initiation.\n5. Active central nervous system metastases and\u002For carcinomatous meningitis.\n6. HIV-infected participants.\n7. History of (non-infectious) pneumonitis or current pneumonitis.\n8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or other agents used in study, such as nivolumab, dacetuzumab, APX005M, ADC-1013.\n9. Prior invasive malignancies within the past 3 years prior to treatment initiation (with the exception of non-melanoma skin cancers, non-invasive bladder cancer, or localized prostate cancer for whom systemic therapy is not required).\n10. Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).\n11. History of chronic autoimmune disease (e.g., Addison's disease, multiple sclerosis, Graves' disease, Hashimoto's thyroiditis, rheumatoid arthritis, hypophysitis, systemic lupus erythematosus, Wegener's granulomatosis, sarcoidosis syndrome, etc.) or other connective tissue diseases with the symptomatic disease within the 3 years of initiation of study treatment. Note: Active vitiligo or a history of vitiligo will not be a basis for exclusion.\n12. Fridericia's corrected QT interval (QTcF) \\>= 480 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n13. Participants who were not able to tolerate prior immune checkpoint inhibitor therapy.\n14. Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n15. Pregnancy.",{"count":343,"type":19},60,[22,23],"Background:\n\nBiliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low.\n\nObjective:\n\nTo test a study drug (CDX-1140) combined 3 other drugs (capecitabine, oxaliplatin, Keytruda) in people with BTC.\n\nEligibility:\n\nAdults aged 18 years or older with BTC that progressed after treatment and is not eligible for surgery or liver transplant.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood tests and tests of their heart function. They will have imaging scans. They may need to have a biopsy: A small sample of tissue will be taken from their tumor using a small needle.\n\nThree of the drugs are given through a tube attached to a needle inserted into a vein in the arm (intravenous). The fourth drug is a pill taken by mouth with water.\n\nParticipants will be treated in 21-day cycles. They will receive intravenous treatments on day 1 and day 8 of the first 6 cycles. After that, they will receive intravenous treatments only on day 1 of each cycle.\n\nParticipants will take the pill twice a day only for the first 2 weeks of each cycle. They will stop taking this drug after 6 cycles.\n\nImaging scans will be repeated every 9 weeks.\n\nParticipants may continue receiving the study treatment for up to 2 years. Follow-up visits, including imaging scans, will continue for 3 more years. These images may be taken at other locations and sent to the researchers.",[347,26,348],"Biliary Cancer","Cancer of the Bile Duct",[299,350,351,352,353],"Pembrolizumab","CAPOX","CDX-1140","CD40 agonist","2026-03-21",{"date":356,"type":52},"2026-03-24",{"date":358,"type":52},"2024-05-08",{"date":360,"type":19},"2042-06-01",{"name":167,"class":168},{"id":363,"slug":4,"hasResults":10,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":368,"targetDuration":4,"studyType":20,"phases":370,"briefSummary":371,"conditions":372,"keywords":441,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":60},"100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist",{"count":369,"type":19},360,[179],"Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[373,374,375,376,89,155,88,81,302,182,377,183,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,84,401,402,403,404,405,406,407,408,26,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,86,430,431,432,433,434,82,435,436,437,438,439,440],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Rectum Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[442,443,444,445,446],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":449,"type":52},"2026-02-20",{"date":451,"type":52},"2021-10-05",{"date":453,"type":19},"2027-03-16",{"name":455,"class":59},"Cedars-Sinai Medical Center",{"id":457,"slug":4,"hasResults":10,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":20,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":276},"100519790","NCT06048133","Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)","Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)","Inclusion Criteria:\n\n1. Patients with cytologically or histologically confirmed BTC by AJCC version 8.\n2. Patients must have late stage (locally advanced, recurrent or metastatic) BTC. Patients must not have received systemic treatment for advanced disease. Prior adjuvant therapy is allowed as long as recurrences occurred 6 months or later from all treatment completion.\n3. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n4. Age ≥ 18 years at the time of consent.\n5. ECOG Performance Status of 0-2 within 28 days prior to registration.\n6. Presence of measurable or evaluable disease, as defined by RECIST v1.1.\n7. Adequate organ function as detailed in the protocol.\n8. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration. NOTE: Biliary cancer may secrete hormones to produce a false-positive pregnancy test. Female subjects of childbearing potential with a positive pregnancy test should have a thorough history and additional work up as determined by the treating physician to rule out pregnancy (e.g. serial βHCG measurements, ultrasound). Once pregnancy has been ruled out, the subject may proceed with screening and enrollment.\n9. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for up to 14 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for up to 11 months after the last dose of study drug(s). See the protocol for specific timeframes for each drug.\n10. Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.\n\nExclusion Criteria:\n\n1. Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC.\n2. Known hypersensitivity to recombinant proteins, or any excipient contained in treatment medication formulations.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n\n   NOTE: participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study.\n4. History of solid organ or allogeneic bone marrow transplantation.\n5. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.\n6. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.\n7. Untreated central nervous system (CNS) metastasis. Screening of asymptomatic patients for CNS metastasis is not required for enrollment.\n8. Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of IP(s) hazardous, including but not limited to\n\n   * Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis.\n   * Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the study treatments.\n9. History of trauma or major surgery within 28 days prior to the first dose of IP. (Note that placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure.\n10. Treatment with palliative radiation therapy within 14 days of study treatment initiation.\n11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n12. Significant dementia or other mental condition that precludes the participant's ability to consent to the study.\n13. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational products.",{"count":463,"type":19},33,[23],"This is a phase 2 study of gemcitabine, cisplatin, zimberelimab (AB122) and quemliclustat (AB680) in subjects with untreated advanced biliary tract cancers (BTC). The study will include a safety run-in involving 6 study participants. The goal of the safety run-in is to screen for early safety signals of the proposed drug combination. Trial enrollment can continue while full safety assessment is being completed for the first 6 subjects.\n\nParticipants will receive 4 cycles of combination therapy as described. After 4 cycles (\\~6 months), cisplatin will be discontinued, while gemcitabine, zimberelimab (AB122), and quemliclustat (AB680) will be continued. Subjects will be treated until disease progression or development of intolerable toxicities. In total, there will be up to 39 participants on the study.",[467,154,26],"Biliary Tract Carcinoma","2026-01-21",{"date":470,"type":52},"2026-01-23",{"date":472,"type":52},"2024-03-08",{"date":474,"type":19},"2027-07",{"name":476,"class":59},"Nataliya Uboha",{"id":478,"slug":4,"hasResults":10,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":283,"enrollmentInfo":484,"targetDuration":4,"studyType":20,"phases":486,"briefSummary":488,"conditions":489,"keywords":493,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":60},"100604900","NCT07155525","Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas","Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial","NBCA-MS","Inclusion Criteria:\n\n* Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.\n* Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).\n* Age 18-75 years .\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function defined as:\n\nHemoglobin ≥ 9.0 g\u002FdL Absolute neutrophil count ≥ 1,500\u002FμL Platelet count ≥ 100,000\u002FμL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) \u002FAlanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal\n\n* Informed consent provided.\n* Willingness to comply with study procedures and follow-up requirements.\n\nExclusion Criteria:\n\n* Hard pancreatic texture (intraoperative surgeon assessment).\n* Emergency surgery.\n* Previous pancreatic surgery or pancreatic anastomosis.\n* Intraoperative identification of unresectable disease\n* Known allergy to cyanoacrylate or components.\n* Pregnancy or lactation.\n* Active infection or sepsis.\n* Inability to comply with follow-up.",{"count":485,"type":19},194,[487],"PHASE3","This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.",[76,490,85,154,491,492,26],"Periampullary Cancer","Pancreatic Ductal Adenocarcinoma","Pancreatic Head Mass",[494,495,496,497,498,499,500,501],"Pancreaticoduodenectomy","Pancreaticojejunostomy","Postoperative Pancreatic Fistula","Soft Pancreas","N-Butyl-2-Cyanoacrylate","Whipple procedure","Tissue adhesive","POPF prevention","2025-09-14",{"date":504,"type":52},"2025-09-18",{"date":506,"type":52},"2025-09-15",{"date":508,"type":19},"2028-11-15",{"name":510,"class":59},"Minia University",{"id":512,"slug":4,"hasResults":10,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":20,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":60},"100438734","NCT04993131","Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma","Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma: a Prospective Exploratory Trial","TESLA II","Inclusion criteria\n\n* Radiologically strong suspicion of pCCA\n* Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein\n* Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery\n* First time pCCA\n* Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction\n* No extrahepatic disease, or lymph node involvement detected on imaging\n* No signs of extrahepatic metastatic disease according to PET-CT scan\n* No signs of extrahepatic metastatic disease according to CT or MR (chest\u002Fabdomen\u002Fpelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit\n* At least 18 years of age\n* Good performance status, Eastern Cooperative Oncology Group (ECOG) score: 0 or 1\n* Satisfactory blood tests Hb \\>10g\u002Fdl, neutrophiles \\>1.0 (after any G-CSF), TRC \\>50, Bilirubin\\\u003C3 x upper normal level, ASAT, ALAT\\\u003C5 x upper normal level, Creatinine \\\u003C1.5 x upper normal level. Albumin above lower normal level, Normal IgG4 levels\n* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national\u002Flocal regulations\n* Received chemotherapy for at least 6 months with at least 10% response according ti RECIST criteria and with no progression of disease at time of Lt\n* At least 10 months from diagnosis\n* Patient must be accepted for transplantation before progressive disease\n* Twelve months or more time span from the diagnosis of pCCA and date of being listed for liver transplantation\n\nExclusion criteria\n\n* Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor\n* Tumor involving main portal vein\n* Tumor involving inferior vena cava\n* Perforation of the visceral peritoneum\n* Weight loss \\>15% the last 6 months\n* Patient BMI \\> 30\n* Other malignancies, except curatively treated more than 5 years ago without relapse\n* Known history of human immunodeficiency virus (HIV) infection\n* Prior history of solid organ or bone marrow transplantation\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Known hypersensitivity to rapamycin\n* Prior extrahepatic metastatic disease\n* Women who are pregnant or breast feeding\n* Any reason why, in the opinion of the investigator, the patient should not participate",{"count":519,"type":19},15,[179],"The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.",[523,524,26],"Perihilar Cholangiocarcinoma","Klatskin Tumor","2025-07-28",{"date":527,"type":52},"2025-07-31",{"date":529,"type":52},"2021-09-01",{"date":531,"type":19},"2045-05-31",{"name":533,"class":59},"Oslo University Hospital",{"id":535,"slug":4,"hasResults":10,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":20,"phases":543,"briefSummary":544,"conditions":545,"keywords":549,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":60},"100460602","NCT05277766","Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer","Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study","PIPAC-NAL-IRI","Inclusion Criteria:\n\n* Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis\n* Estimated life expectancy \\> 6 months; \\> 3 months if primary cancer is pancreatic\n* Age ≥ 18 years\n* Adequate performance status (Karnofsky index \\> 60% and WHO performance status \\\u003C 2)\n* Written informed consent obtained prior any act of the research\n\nExclusion Criteria:\n\n* Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)\n* Pregnancy or breastfeeding during the clinical study\n* Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic).\n* Known allergy or intolerance to irinotecan\n* Significant amount of ascites detectable (exceeding 3l in volume)\n* Intestinal or urinary tract obstruction\n* Extensive hepatic and\u002For extra-abdominal metastatic disease\n* Impaired renal function (serum creatinine \\> 1.5 mg\u002Fdl or calculated GFR (CKD-EPI) \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n* Impaired liver function (serum total bilirubin \\> 1.5 mg\u002Fdl, except for known Gilbert's disease)\n* Platelet count \\\u003C 100.000\u002Fµl\n* Hemoglobin \\\u003C 9g\u002Fdl\n* Neutrophil granulocytes \\\u003C 1.500\u002Fml\n* Patients known to use:\n\n  * CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort)\n  * inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)",{"count":542,"type":19},45,[22],"The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial.",[546,547,211,548,407,87,76,26],"Peritoneal Carcinomatosis","Peritoneal Metastases","Small Bowel Cancer",[550,551,552,553,554,555,556,557,558,559,560,561,562,563,154,564,565],"PIPAC","Nal-IRI","Peritoneal carcinomatosis","dose-finding study","pharmacokinetics","pharmacodynamics","safety and efficacy","Onivyde","Primary gastrointestinal cancer","Colorectal cancer","Small bowel cancer","Appendix cancer","Stomach cancer","Pancreatic cancer","dose-escalation study","Peritoneal metastases","2025-06-26",{"date":307,"type":52},{"date":569,"type":52},"2022-11-21",{"date":571,"type":19},"2027-04",{"name":573,"class":59},"University Hospital, Ghent",{"id":575,"slug":4,"hasResults":10,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":20,"phases":582,"briefSummary":583,"conditions":584,"keywords":588,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":60},"100595725","NCT07036185","A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors","An Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KJ015 Injection (Subcutaneous Injection) in Patients With HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n1. Aged ≥ 18 years (at time of free and informed consent).\n2. Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior to the first dose of enrollment.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) Dose Escalation Part: ECOG performance status 0 to 1;Backfill Part: ECOG performance status0 to 2.\n4. Participants must be have HER 2 positive or HER 2 expressing tumors determined by a certified local or central clinical laboratory or hospital\n5. Organ function must meet the following criteria:\n\n   i.Hemoglobin (Hb) ≥ 9.0 g\u002FdL ii.Absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL iii.Platelet count (PLT) ≥ 80 × 109\u002FL v.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN if no liver lesions (primary or metastatic); ALT and AST ≤ 5 × ULN if liver lesions are present vi.Creatinine clearance ≥ 30 mL\u002Fmin vii.Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN viii. Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL).\n6. Expected survival ≥ 3 months.\n7. Participants must be capable of and willing to comply with the visit and procedure requirements outlined in the protocol.\n\nExclusion Criteria:\n\n1. Concurrent participation in another clinical study.\n2. Received radiotherapy within 2 weeks prior to the first dose.\n3. Underwent major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose or plan to undergo major surgery during the study. Underwent interventional or ablation surgery aimed at treating the tumor within 2 weeks before the first dose.\n4. Prior allogeneic bone marrow transplant or prior solid organ transplant.\n5. Received systemic corticosteroids or other immunosuppressive treatments within 2 weeks prior to the first dose.\n6. Received an anthracycline cumulative dose of doxorubicin exceeding 500 mg\u002Fm2 or an equivalent dose of other anthracyclines prior to the first dose.\n7. History of leptomeningeal carcinomatosis or carcinomatous meningitis.\n8. Brain metastasis or spinal cord compression.\n9. Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.\n10. History of a serious allergic reaction to the investigational product, an inactive ingredient in the investigational product, or other monoclonal antibody.\n11. Women who are pregnant or breastfeeding as confirmed by pregnancy testing within 3 days prior to first dose.",{"count":581,"type":19},66,[22],"This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors.",[585,28,211,586,26,587],"Gastric\u002FGastroesophageal Junction Cancer","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma",[589,590,591],"KJ015","HER2","solid tumors","2025-06-16",{"date":594,"type":52},"2025-06-25",{"date":596,"type":19},"2025-06-24",{"date":598,"type":19},"2027-04-30",{"name":600,"class":601},"Shanghai Bao Pharmaceuticals Co., Ltd.","INDUSTRY",{"id":603,"slug":4,"hasResults":10,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":609,"enrollmentInfo":610,"targetDuration":612,"studyType":73,"phases":4,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":629},"100537415","NCT06277531","Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)","Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE): a Prospective Cohort Study","ECCBILE","Inclusion Criteria:\n\n* Patients is suspected indetermined biliary strictures\n* Patients have the indication for ERCP\n\nExclusion Criteria:\n\n* ERCP failed, or can not obtain bile\n* Sever comorbidities\n* Predicted overall survival less than 1 year because of other disease\n* Patients who are unlikely to comply with the protocol, inability to return for subsequent visits","85 Years",{"count":611,"type":19},99,"1 Year","Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.\n\nBrush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.\n\nIn the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.",[615,26,155],"Biliary Stricture",[617,618,619],"Malignant Biliary Stricture","Cell-Free Extrachromosomal Circular DNA (eccDNA)","Liquid-Biopsies Assay","2025-05-22",{"date":622,"type":52},"2025-05-28",{"date":624,"type":52},"2024-03-01",{"date":626,"type":19},"2026-07-01",{"name":628,"class":59},"Peking University Third Hospital",2,{"id":631,"slug":4,"hasResults":10,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":20,"phases":639,"briefSummary":640,"conditions":641,"keywords":643,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":4},"100572231","NCT06730581","Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors","Phase II Clinical Trial of Utidelone Capsule in the Treatment of Advanced Solid Tumor Patients","Inclusion Criteria:\n\n\\-\n\n1、 For participants with advanced gastric cancer:Histologically and\u002For cytologically confirmed unresectable HER2-negative locally advanced or recurrent\u002Fmetastatic gastric or gastroesophageal junction adenocarcinoma (according to the 2019 WHO Classification of Digestive System Oncology).\n\n2、 For participants with advanced cholangiocarcinoma:Histologically and\u002For cytologically, patients were diagnosed with surgically unresectable advanced or metastatic cholangiocarcinoma.\n\n3、 For participants with advanced ovarian cancer:A histologically or pathologically confirmed diagnosis of high-grade serous ovarian cancer was consistent with platinum-resistant recurrent ovarian cancer (progression within 6 months after the last platinum-based chemotherapy) according to the 2020 WHO histopathological classification of ovarian tumors.\n\n4、 For participants with other tumors:\n\n1. Esophageal cancer: locally advanced recurrent or metastatic squamous esophageal cancer confirmed by histology or cytology.\n2. Hepatocellular carcinoma: clinically diagnosed or histologically\u002Fcytologically confirmed diagnosis of inoperable resectable or metastatic hepatocellular carcinoma (HCC) (according to the Guidelines for the Management of Primary Hepatocellular Carcinoma (2024 edition)); Child-Pugh score ≤ 7.\n3. Colorectal cancer: unresectable advanced\u002Fmetastatic colorectal cancer (mCRC) confirmed by histology or cytology.\n4. Recurrent or metastatic cervical cancer confirmed by histopathology, not amenable to radical surgical resection and\u002For radical radiotherapy, and pathologic type of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n\n5、For all participants:\n\n1. Subjects must give informed consent to the study prior to the study, and voluntarily sign a written informed consent form (ICF), understanding and agreeing to comply with the study requirements and test procedures;\n2. ≥18 years old and ≤70 years old;\n3. According to RECIST v1.1, patients had at least one target lesion (non-radiotherapy field) that could be measured by computed tomography (CT) or magnetic resonance imaging (MRI) (longest diameter ≥10mm, lymph node diameter ≥15mm, scan layer thickness ≤ 5mm).\n4. Have received at least one standard systemic therapy, and the number of previous systemic anti-tumor therapy lines is ≤4 (neoadjuvant and adjuvant chemotherapy regiments are not considered prior systemic therapy unless disease progression occurs during their chemotherapy or within 6 months after the last chemotherapy);\n5. The blood routine examination within 1 week before enrollment was basically normal (the normal value of the laboratory of each research center was the standard); No rhG-CSF, blood transfusion \u002FEPO and other drugs were used within 14 days before enrollment.\n\n   a. White blood cell count (WBC) ≥3.5 × 109\u002FL b.Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; c.Platelet count (PLT) ≥ 100 × 109\u002FL; d.Hemoglobin ≥ 9.0 g\u002FdL.\n6. Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory):\n\n   a.Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) b.SGPT\u002FALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); c.SGOT\u002FAST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); d.The creatinine clearance rate (Ccr) is ≥ 60 ml\u002Fmin (Cockcroft Gault formula).\n7. adequate coagulation function, defined as INR or PT ≤1.5 times ULN; If the subject was receiving anticoagulant therapy, as long as the PT was within the prescribed range of anticoagulant drugs.\n8. ECOG 0-1 with an expected survival of more than 12 weeks;\n9. Patients of childbearing potential had to consent to use a reliable contraceptive method (hormonal or barrier methods or abstinence) with their partner simultaneously during the trial and for at least 3 months after the last dose; Female patients of reproductive age had to have a negative blood or urine pregnancy test before enrollment.\n\nExclusion Criteria:\n\n\\-\n\n1、 For participants with advanced gastric cancer:Patients with HER2-positive disease.\n\n2、 For participants with advanced ovarian cancer: 1) Having a clear cell, mucinous or sarcomatous histology, containing mixed tumours of any histological type, or low grade\u002Fborderline ovarian cancer; 2) Platinum-refractory ovarian cancer: tumor progression assessed within 1 month after the last dose of platinum therapy.\n\n3、 For all participants:\n\n1. Other malignancies within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid;\n2. Received nitrosourea or mitomycin C within 6 weeks prior to the first use of the study drug; Anti-tumor therapy, including chemotherapy, radiotherapy, biotargeted therapy, immunotherapy, etc. within 4 weeks or 5 half-lives (whichever is shorter) prior to the first use of the investigational drug; Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug, whichever is shorter; Use of traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks prior to the first use of the investigational drug.\n3. had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or required elective surgery during the trial period.\n4. Patients with peripheral neuropathy CTCAE 5.0 grade ≥2.\n5. The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risk judged by investigators, such as alopecia).\n6. Patients who had previously used Utidelone injection.\n7. Patients with gastrointestinal bleeding, active gastrointestinal ulcers or gastrointestinal obstruction (including paralytic ileus), gastrointestinal perforation or fistula, and intraperitoneal abscesses within 6 months prior to the first use of the investigational drug;\n8. Patients with dysphagia, or other factors that affect the oral administration and absorption of drugs, or who require parenteral nutrition;\n9. Clinically active brain metastases, spinal cord compression, or spread of pia meningioma, defined as symptomatic or requiring steroid hormone or anticonvulsant therapy to control related symptoms; Patients with confirmed progression of brain metastases within 2 months after radiotherapy or other local treatment;\n10. Clinically severe lung injury caused by concurrent lung disease, including but not limited to any underlying lung disease (i.e., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc., with clinical symptoms requiring intervention within 3 months prior to the first use of the investigational drug);\n11. Patients with clinical symptoms of cancerous ascites, pleural effusion and pericardial effusion requiring puncture and drainage; Or had undergone drainage of ascites, pleural effusion, or pericardial effusion within 30 days prior to the first use of the study drug.\n12. Imaging shows that the tumor has invaded the vicinity of important blood vessels or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding;\n13. Have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:\n\n    1. Have severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree Ⅱ-Ⅲ atrioventricular block, etc.; At rest, QTcF\\> 450 ms in men or 470ms in women was examined by 12-lead electrocardiogram (Fredericia's formula, see Appendix IV);\n    2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular event within 6 months prior to first use of the study drug;\n    3. Clinically uncontrollable hypertension;\n    4. Other researchers have identified a high risk of heart disease.\n14. Patients with uncontrolled diabetes within 3 months prior to first use of the study drug.\n15. Patients with active hepatitis B and\u002For hepatitis C, i.e. HBsAg positive and\u002For HBcAb positive with HBV DNA positive and\u002For anti-HCV positive and HCV RNA positive; Positive for human immunodeficiency virus (HIV) antibodies; The specific antibody of treponema pallidum was positive.\n16. Those who have an active infection and currently require systemic anti-infective therapy.\n17. Had an active autoimmune disease that required systemic treatment (i.e., disease modulators, corticosteroids, or immunosuppressive drugs) within 2 years prior to enrollment. Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a systemic treatment.\n18. Women who are pregnant or nursing or plan to become pregnant during the study period.\n19. Patients with mental disorders or poor compliance.\n20. Known allergy to the investigational drug or any of its excipients.\n21. Concurrent participation in another interventional clinical trial or use of another investigational treatment.\n22. The researchers believe that the subjects have a history of serious systemic disease, or other reasons should not be enrolled in this study.","70 Years",{"count":638,"type":19},100,[23],"This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.",[642,30,26],"Gastric Cancer Adenocarcinoma Metastatic",[87,30,38],"2024-12-08",{"date":646,"type":52},"2024-12-12",{"date":648,"type":19},"2024-12-01",{"date":650,"type":19},"2026-12-31",{"name":652,"class":601},"Beijing Biostar Pharmaceuticals Co., Ltd.",{"id":654,"slug":4,"hasResults":10,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":660,"targetDuration":662,"studyType":73,"phases":4,"briefSummary":663,"conditions":664,"keywords":668,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":60},"100570743","NCT06711211","Spanish Registry of Digestive Tumours RETUD","A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours","RETUD","Inclusion Criteria:\n\n* Male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer.\n* Written informed consent available.\n\nExclusion Criteria:\n\n* Patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.",{"count":661,"type":19},20000,"10 Years","The aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients.\n\nThe study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in Spain. It also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. COVID-19 coronavirus pandemic).\n\nFurthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.",[665,26,666,667,76,82],"Digestive Cancers","Hepatocellular Cancer (HCC)","Colorectal Cancer (CRC)",[669,670,671,672,673,674,675,676],"digestive","cancer","tumours","cholangiocarcinoma","hepatocellular","colorectal","pancreas","rectal","2024-11-27",{"date":679,"type":52},"2024-12-02",{"date":681,"type":52},"2020-12-23",{"date":683,"type":19},"2030-12",{"name":685,"class":59},"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)",{"id":687,"slug":4,"hasResults":10,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":692,"enrollmentInfo":693,"targetDuration":4,"studyType":20,"phases":695,"briefSummary":696,"conditions":697,"keywords":705,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":709,"lastUpdatePostDateStruct":710,"startDateStruct":712,"completionDateStruct":713,"leadSponsor":714,"locationsCount":60},"100542265","NCT06340620","EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope","Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Any patient undergoing EUS examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Unable to obtain consent for the procedure from either the patient or LAR.\n* Intrauterine pregnancy.","100 Years",{"count":694,"type":19},140,[179],"This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.",[698,76,699,700,701,26,702,703,704],"Pancreatic Disease","Pancreatic Cyst","Gastrointestinal Tumor","Bile Duct Diseases","Lymph Node Disease","Submucosal Tumor of Gastrointestinal Tract","Gastrointestinal Cancer",[706,707,708],"Endoscopic ultrasound","EndoSound Vision System","Randomized trial","2024-03-25",{"date":711,"type":52},"2024-04-01",{"date":709,"type":19},{"date":193,"type":19},{"name":715,"class":59},"Orlando Health, Inc.",{"id":717,"slug":4,"hasResults":10,"nctId":718,"briefTitle":719,"officialTitle":720,"acronym":721,"eligibilityCriteria":722,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":723,"targetDuration":4,"studyType":20,"phases":725,"briefSummary":726,"conditions":727,"keywords":728,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":60},"100529597","NCT06175845","Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma","Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma","ACTICCA-2","Inclusion Criteria:\n\n1. Unresectable perihilar and\u002For ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT)\n2. Written informed consent\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n4. Age ≥18 years\n5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT\n6. No prior radiofrequency ablation (RFA) for CCA\n7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months)\n8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent",{"count":724,"type":19},130,[179],"The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are:\n\n* Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?\n* Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).",[154,524,26,88],[263,729,730,731,732,733,734,735],"Intraductal","Biliary","Endoscopic retrograde cholangiography","Transpapillary","Stent dysfunction","Cholangitis","Obstruction","2023-12-08",{"date":738,"type":52},"2023-12-19",{"date":740,"type":19},"2024-02",{"date":742,"type":19},"2026-07",{"name":744,"class":59},"Universitätsklinikum Hamburg-Eppendorf",{"id":746,"slug":4,"hasResults":10,"nctId":747,"briefTitle":748,"officialTitle":749,"acronym":4,"eligibilityCriteria":750,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":751,"targetDuration":4,"studyType":20,"phases":752,"briefSummary":753,"conditions":754,"keywords":756,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":760,"lastUpdatePostDateStruct":761,"startDateStruct":763,"completionDateStruct":765,"leadSponsor":767,"locationsCount":629},"100519432","NCT06043466","A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors","Phase I Clinical Study of Chimeric Antigen Receptor T Cells (C-13-60) in the Treatment of Carcinoembryonic Antigen (CEA) Positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Patients with advanced malignant solid tumors confirmed by histology or pathology, including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, non-small cell lung cancer, breast cancer, and cholangiocarcinoma;\n3. Progression or intolerance occurs after receiving systematic standard therapy according to guidelines,(systemic therapy including but not limited to systemic chemotherapy, molecular targeting, etc.) and is not suitable for surgery or local therapy (including ablative therapy, interventional therapy, and radiation therapy), among which colorectal cancer needs to receive at least third-line therapy failure or intolerance or inapplicability. Esophageal, gastric, non-small cell lung, breast, and cholangiocarcinoma require at least second-line treatment failure or intolerance or inadequacy, and pancreatic cancer require at least first-line treatment failure or intolerance or inadequacy:\n\n   1. Advanced colorectal cancer: progression or intolerance or inadequacy after third-line standard therapy including cetuximab ± Irinotecan\u002Fregorafenib \u002Ffruquintinib\u002Ftrifluridine；\n   2. Advanced or metastatic esophageal cancer\u002Fesophagogastric junction cancer: patients with esophageal cancer who progress or are intolerant or inapplicable after second-line therapy including PD-1 MAB \u002FPD-L1 mab; Patients with esophagogastric junction cancer progressed or were intolerant or inapplicable after second-line therapy including taxane or irinotecan or PD-1 \u002FPD-L1 monoclonal antibody; For HER-2 positive patients, trastuzumab containing system therapy should fail or be intolerable or not applicable;\n   3. Advanced\u002Fmetastatic gastric cancer: the combination of PD-1 MAB \u002FPD-L1 MAB and chemotherapy has been developed or is not tolerated or suitable; For HER-2 positive patients, systemic treatment containing trastuzumab should fail or be intolerable or inapplicable.\n   4. Patients with advanced, metastatic, or recurrent non-small cell lung cancer who have received systemic treatment progression or intolerance, including: Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance (squamous cell carcinoma does not require driver gene testing). In addition, patients with EGFR-positive driver gene who are resistant to first-line EGFR-Tkis and who are positive for EGFR T790M mutations need to be treated with third-generation EGFR-TKI (such as Osimertinib, almonertinib, or furmonertinib) after failure or resistance. For patients with positive ALK fusion and drug resistance after first-line crizotinib treatment, second-line treatment with ceritinib or alectinib should fail or be resistant; Patients with PD-L1 expression (PD-L1 TPS≥1%) should undergo immune checkpoint inhibitor treatment failure or intolerance; In patients with negative driver genes, the disease progresses or becomes intolerable after chemotherapy with platinum-containing regiments-such as Camrelizumab, Pembrolizumab, Tislelizumab, Sintilimab or Atezolizumab combined with pemetrexed\n   5. Advanced, metastatic breast cancer: HER-2 positive patients need to have received anti-HER-2 therapy, hormone receptor positive patients need to receive endocrine therapy and other standard treatments have failed or are intolerable or not applicable, and rescue chemotherapy for those who have failed\u002Fare intolerable or triple-negative breast cancer (including: Gemcitabine + cisplatin\u002Fcarboplatin, albumin paclitaxel\u002Fother taxoid drugs + cisplatin\u002Fcarboplatin) fail or are not tolerated or suitable;\n   6. Locally advanced or metastatic pancreatic cancer: advanced or intolerant or inappropriate after at least first-line treatment, including: Gemcitabine + albumin-bound paclitaxel\u002Fcisplatin\u002Ferlotinib\u002Fcapecitabine\u002Ftegafur\u002FNimotuzumab, or FOLFIRINOX (oxaliplatin + irinotecan +LV+5-FU), or mFOLFIRINOX (oxaliplatin + irinotecan + calcium folinate +5-FU);\n   7. Advanced cholangiocarcinoma: progression or intolerance or inapplicability after at least second-line therapy (mFOLFOX); Remarks: Chemotherapy failure is defined as disease progression or intolerable toxicity during treatment or within 3 months after the last dose; If patients cannot receive the above treatment for economic reasons, those whose benefits outweigh the risks of inclusion in the study can be enrolled.\n4. Subjects with positive CEA (IHC score 3+) in tumor tissue samples (paraffin sections or fresh tissue specimens or puncture biopsy samples) within 3 months before screening; If the immunohistochemical results of the tumor samples are more than 3 months from the time of screening, the patient needs to re-biopsy; If the tumor specimens are not available or the amount is too small for immunohistochemical detection of CEA, the CEA positive can be confirmed by re-staining of previous tissue specimens, and the peripheral blood serum CEA≥2.0×ULN can be included in the group.\n5. Have at least one evaluable target lesion according to RECIST 1.1 criteria;\n6. Colorectal cancer, esophageal cancer, non-small cell lung cancer, breast cancer, stomach cancer, cholangiocarcinoma ECOG 0 \\~ 1 score, pancreatic cancer ECOG 0 \\~ 2 score;\n7. Expected survival time is more than 12 weeks;\n8. No serious mental disorders;\n9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:\n\n   1. Blood routine: white blood cells \\> 3.5×109\u002FL, neutrophils \\> 1.8×109\u002FL, lymphocytes \\> 0.5 ×109\u002FL, platelet \\> 80×109\u002FL, hemoglobin \\> 90g\u002FL;\n   2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n   3. Renal function: serum creatinine ≤2.0×ULN;\n   4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0 ×ULN);\n   5. Total bilirubin ≤2.0×ULN (Gilbert syndrome ≤3.0×ULN; The patients with liver tumor infiltration can be enlarged to ≤5.0×ULN);\n   6. Blood oxygen saturation in non-oxygen state \\> 92%.\n10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;\n11. The subject agrees to use a reliable and effective method of contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the C-13-60 cell infusion. Including but not limited to: abstinence, can inhibit ovulation implantable progesterone contraceptive; Intrauterine device (IUD); Intrauterine hormone release system; Spousal vasectomy; Combined hormonal contraceptives (oral, vaginal, and transdermal) that inhibit ovulation; Progesterone contraceptives (oral or injectable) that inhibit ovulation; Male subjects who have sex with fertile women must consent to the use of a barrier method of contraception (e.g., condom plus spermicidal foam\u002Fgel\u002Ffilm\u002Femulsion\u002Fsuppository). At the same time, the subject should promise not to donate eggs (egg cells, oocytes) or sperm for assisted reproduction within 1 year after the cell infusion.\n12. The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. People who have received CAR-T therapy or other gene-modified cell therapy;\n2. Patients with BMS with clinical symptoms or lesions located in key parts of the brain at the time of screening, patients with BMS without clinical symptoms or lesions located in non-critical parts of the brain should be evaluated by researchers or specialists to gain more than the risk.\n3. Received any of the following medications or treatments before screening:\n\n   1. Received other investigational drugs or treatments that are not on the market within 4 weeks prior to screening;\n   2. Received live attenuated vaccine within 4 weeks prior to screening;\n   3. Received radioactive iodine-125 particle implantation within 8 weeks prior to screening;\n4. Received the following drugs or treatments before apheresis:\n\n   1. received the equivalent of \\&gt within 2 weeks prior to apheresis; 10mg\u002F day of prednisone for systemic steroids, except inhaled steroids;\n   2. Received anti-PD-1 \u002F PD-L1 monoclonal antibody treatment within 4 weeks before apheresis; Received chemotherapy, targeted therapy, or other investigational agents within 2 weeks of preapheresis or at least 5 drug half-lives (whichever is shorter);\n5. There is an active or uncontrolled infection that requires systemic treatment within 1 week prior to screening;\n6. Subjects with intestinal obstruction, active gastrointestinal bleeding, history of massive gastrointestinal bleeding within 3 months, severe gastroduodenal ulcer, severe ulcerative colitis and other severe intestinal inflammation;\n7. History of severe respiratory disease;\n8. There are a large number of serous effusions that cannot be controlled by treatment (such as pleural effusions, abdominal effusions and pericardial effusions);\n9. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy.\n10. Known to have active or uncontrolled autoimmune diseases that require treatment with immunosuppressants, including biologics, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;\n11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA test greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Human immunodeficiency virus (HIV) antibody positive; Syphilis positive; Cytomegalovirus (CMV) DNA test positive;\n12. At the time of screening, subjects had venous embolism events (e.g., pulmonary embolism) and required anticoagulant therapy;\n13. Other uncured malignant tumors within the past 3 years or at the same time, except cervical carcinoma in situ and skin basal cell carcinoma;\n14. Women who are pregnant or nursing, and male or female subjects who plan to have a child within 1 year after receiving C-13-60 cell transfusion;\n15. Circumstances deemed unsuitable for participation in the study by other researchers.",{"count":319,"type":19},[22],"This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.",[211,426,87,155,755,28,26],"Non-small Cell Lung Cancer",[757,758,759],"CAR-T","CEA","CEA-positive advanced\u002Fmetastatic solid tumors","2023-09-18",{"date":762,"type":52},"2023-09-21",{"date":764,"type":52},"2023-08-11",{"date":766,"type":19},"2027-12-31",{"name":768,"class":601},"Chongqing Precision Biotech Co., Ltd",{"id":770,"slug":4,"hasResults":10,"nctId":771,"briefTitle":772,"officialTitle":773,"acronym":774,"eligibilityCriteria":775,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":776,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":778,"conditions":779,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":787,"lastUpdatePostDateStruct":788,"startDateStruct":790,"completionDateStruct":792,"leadSponsor":794,"locationsCount":60},"100518298","NCT06028724","A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","POPCORN","Inclusion Criteria:\n\nPatients eligible for inclusion in this study have to meet all of the following criteria:\n\n* Patients, 18 years of age or older\n* Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n* Histologically proven diagnosis solid tumor\n* Diagnosis of advanced or locally advanced disease\n* Patients candidated to receive standard therapy in the following line:\n* first, second or third-line therapy for colon-rectal cancer in IV stage\n* first or second-line therapy for gastric cancer in IV stage\n* primary intent or first-line therapy for pancreatic cancer\n* first-line therapy for bile duct cancer\n* first or second-line therapy for hepatocarcinoma\n* first, second, third, fourth or fifth-line therapy for breast cancer in IV stage\n* chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse\n* first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)\n* first or second-line therapy for advanced or locally advanced cervical cancer\n* therapy for locally advanced or first line therapy for metastatic vulva cancer\n* first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)\n\nExclusion Criteria:\n\n* Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints",{"count":777,"type":19},782,"The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.",[780,781,782,783,87,76,26,784,28,30,117,785,786,113],"Solid Tumor","Advanced Solid Tumor","Locally Advanced Solid Tumor","Colon Rectal Cancer","Hepatocarcinoma","Cervical Cancer","Vulva Cancer","2023-09-08",{"date":789,"type":52},"2023-09-13",{"date":791,"type":52},"2023-05-26",{"date":793,"type":19},"2030-05-31",{"name":795,"class":59},"Centro di Riferimento Oncologico - Aviano",{"id":797,"slug":4,"hasResults":10,"nctId":798,"briefTitle":799,"officialTitle":800,"acronym":4,"eligibilityCriteria":801,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":802,"targetDuration":662,"studyType":73,"phases":4,"briefSummary":804,"conditions":805,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":811,"lastUpdatePostDateStruct":812,"startDateStruct":814,"completionDateStruct":815,"leadSponsor":817,"locationsCount":60},"100451236","NCT05155878","Prognostic Factors in Periampullary Tumors and Cysts","Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region","Inclusion Criteria:\n\n* Recommended surgery for tumor or cyst in the pancreas or periampullary region\n* Information avalible in electronic journal files\n* Informed consent (or deceased for retrospective part of the study)\n\nExclusion Criteria:\n\n* No informed consent (and still alive at study initiation)",{"count":803,"type":19},500,"The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.",[155,806,807,808,809,26,490,158,810],"Pancreas Neoplasm","Pancreas Cyst","Pancreatic Fistula","Pancreas Disease","Surgery--Complications","2021-12-13",{"date":813,"type":52},"2022-01-05",{"date":529,"type":52},{"date":816,"type":19},"2040-01-01",{"name":818,"class":59},"Umeå University",""]