[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gall-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gall-bladder-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,62,100,127,167,238,250,295,324,359,388,410,438,463],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100053405","phase-1-atezolizumab-plus-tivozanib-in-immunologically-cold-tumor-types-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":19,"type":20},29,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28,29,30,31,32,33,34,35],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[37,38,39,40,41,42,43,44,45,46,47,48],"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":52,"type":53},"2026-07-13","ACTUAL",{"date":55,"type":53},"2021-12-07",{"date":57,"type":20},"2027-06",{"name":59,"class":60},"University of Florida","OTHER",1,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":70,"type":20},104,[72],"NA","This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[75,76,77,29,78,79,80,81,28,82,83,84,85,86,31,87,35,88,89],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Pancreatic Cancer","Rectal Cancer","Sarcoma","2026-07-01",{"date":92,"type":53},"2026-07-02",{"date":94,"type":53},"2026-02-11",{"date":96,"type":20},"2027-08-31",{"name":98,"class":60},"Alliance for Clinical Trials in Oncology",18,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":61},"100523866","locally-ablative-therapy-for-oligo-progressive-gastrointestinal-malignancies-livelong-100523866","NCT06101277","Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)","LIVELONG","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed cancers:\n\n   1. Cohort A: (Cohort removed in protocol version 4.0)\n   2. Cohort B: Small bowel\n   3. Cohort C: Pancreatic and ampullary, colorectal, and appendiceal\n   4. Cohort D: (Cohort removed in protocol version 4.0)\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",{"count":108,"type":20},300,[72],"This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[112,113,114,115,28,116,117,118],"Small Bowel Cancer","Colorectal Cancer","Appendiceal Cancer","Biliary Cancer","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Oligoprogressive","2026-06-30",{"date":92,"type":53},{"date":122,"type":53},"2023-10-05",{"date":124,"type":20},"2039-09-15",{"name":126,"class":60},"University of California, Davis",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":166},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":137,"type":20},100,"OBSERVATIONAL","This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[141,76,142,78,80,81,28,143,86,84,144,145,146,147,31,87,35,148,149,89,150,151,152,153,154,155,34],"Adenocarcinoma (NOS)","Bladder Cancer","Gastrointestinal Stromal Tumour","Melanoma","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Renal Cell Carcinoma","Salivary Gland Cancer","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","2026-06-26",{"date":158,"type":53},"2026-06-29",{"date":160,"type":53},"2025-09-18",{"date":162,"type":20},"2028-03-30",{"name":164,"class":165},"AstraZeneca","INDUSTRY",17,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":15,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":200,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":108,"type":20},[23,24],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[179,180,181,182,85,31,80,35,113,29,183,184,86,28,150,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Other Cancer","Locally Advanced","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-06-24",{"date":156,"type":53},{"date":232,"type":53},"2020-10-29",{"date":234,"type":20},"2027-12-31",{"name":236,"class":165},"PMV Pharmaceuticals, Inc",77,{"id":239,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":241,"briefSummary":25,"conditions":242,"keywords":243,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":248,"leadSponsor":249,"locationsCount":61},"100439284",{"count":19,"type":20},[23,24],[27,28,29,30,31,32,33,34,35],[37,38,39,40,41,42,43,44,45,46,47,48],"2026-06-04",{"date":246,"type":53},"2026-06-05",{"date":55,"type":53},{"date":57,"type":20},{"name":59,"class":60},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":257,"targetDuration":258,"studyType":138,"phases":4,"briefSummary":259,"conditions":260,"keywords":274,"overallStatus":285,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":61},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888","NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.",{"count":108,"type":20},"5 Years","Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[261,262,28,263,264,265,266,267,268,269,270,271,272,273],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Biliary Tract Cancers (BTC)","Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[275,264,116,117,276,277,278,279,280,281,282,283,284],"Biliary Tract Neoplasms","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","NOT_YET_RECRUITING","2026-03-02",{"date":288,"type":53},"2026-03-06",{"date":290,"type":20},"2026-03-15",{"date":292,"type":20},"2031-12-30",{"name":294,"class":60},"Aarhus University Hospital",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":61},"100618917","prospective-evaluation-of-68ga-fapi-pet-in-biliary-cancers-100618917","NCT07337850","Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers","FAP 2: Utility of Gallium-68-Fibroblast Activation Protein Inhibitor (FAPI) PET in Biliary Tract Cancers: A Prospective Study","FAPi-2","Inclusion Criteria:\n\n* Suspected biliary tract cancers- iHCC and GBC\n* Male and females ≥ 18 years;\n* Upfront advanced (suspected T3 ,T4, N1, vascular involvement)\n* iGBC (residual, N1)\n* Suspected post-treatment recurrence (biochemical or radiological)\n\nExclusion Criteria:\n\n* Informed consent withdrawal\n* Concurrent Malignancy","90 Years",{"count":305,"type":20},60,"The goal of this prospective observational study is to evaluate whether Gallium-68 Fibroblast Activation Protein Inhibitor (FAPI) PET\u002FCT can improve detection, staging, and recurrence assessment in adult patients (≥18 years) with suspected or confirmed biliary tract cancers, including gallbladder cancer, cholangiocarcinoma, and post-treatment suspected recurrence.\n\nThe main question(s) this study aims to answer are:\n\nCan FAPI PET\u002FCT provide greater sensitivity, specificity and diagnostic accuracy for primary tumors, nodal disease, and metastatic lesions compared to standard FDG PET\u002FCT?\n\nDoes FAPI PET\u002FCT offer additional diagnostic yield that may affect clinical decision-making and staging, potentially reducing need for invasive staging procedures?\n\nResearchers will compare FAPI PET\u002FCT with FDG PET\u002FCT to see if FAPI improves detection of metastatic or recurrent disease, especially peritoneal or liver metastasis and lymph node involvement.\n\nParticipants will:\n\nProvide written informed consent.\n\nUndergo FAPI PET\u002FCT imaging (baseline and\u002For at suspected biochemical or radiologic recurrence).\n\nHave quantitative imaging parameters evaluated (SUVmax, tumor-to-liver ratios, metabolic volume).\n\nMay undergo comparison with FDG PET\u002FCT and\u002For follow-up imaging or histopathology as gold standard.",[28,308],"Intrahepatic Cholangiocarcinoma (Icc)",[310,311,312,313,264,314],"FAPI PET\u002FCT","Gallium-68 FAPI","Biliary Tract Cancer","Gallbladder Cancer","Intrahepatic Cholangiocarcinoma (iHCC)","2026-01-01",{"date":317,"type":53},"2026-01-13",{"date":319,"type":53},"2024-09-25",{"date":321,"type":20},"2026-03",{"name":323,"class":60},"Tata Memorial Centre",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":333,"briefSummary":334,"conditions":335,"keywords":341,"overallStatus":285,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100612367","phase-1-study-of-acc-1898-in-adult-participants-with-advanced-solid-tumors-100612367","NCT07252661","Study of ACC-1898 in Adult Participants With Advanced Solid Tumors","An Open-Label, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACC-1898 (Tyrosine Kinase Inhibitor) in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria (highlights):\n\nAdults (≥ 18 years) with histologically confirmed advanced or metastatic solid tumors that have progressed after standard therapy or for which no effective standard option exists.\n\nAt least one measurable lesion per RECIST v1.1.\n\nECOG (Eastern Cooperative Oncology Group) Performance Status 0-1 (2 may be allowed with Medical Monitor approval).\n\nResolved acute effects from prior therapy to ≤ Grade 1 per CTCAE v5.0.\n\nAdequate organ function (hematologic, hepatic, renal).\n\nAble to swallow oral medication and comply with study requirements.\n\nSigned informed consent.\n\nWomen of childbearing potential must have a negative pregnancy test and use highly effective contraception during and for 180 days after treatment; men must use condoms and avoid sperm donation for 120 days post-treatment.\n\nExclusion Criteria (highlights):\n\nKnown primary CNS (central nervous system) malignancy or symptomatic brain metastases requiring supraphysiologic steroids (unless stable ≥ 3 months after therapy).\n\nActive or uncontrolled infection (including HBV, HCV, HIV) not meeting protocol control criteria.\n\nHBV: Hepatitis B Virus HCV: Hepatitis C Virus HIV: Human Immunodeficiency Virus\n\nSignificant GI disease that could impair oral drug absorption (e.g., unresolved Grade \\> 1 nausea\u002Fdiarrhea).\n\nActive liver or biliary disease (except stable metastases or Gilbert's syndrome).\n\nBaseline QTcF (QT Interval Corrected Using Fridericia Formula) \\> 450 msec (men) or \\> 470 msec (women), clinically significant ECG abnormalities, or heart rate \\\u003C 45 bpm unless approved by cardiology review.\n\nPregnant or breastfeeding women.\n\nAny other medical condition that, in the investigator's judgment, would interfere with study participation or pose unacceptable risk.",{"count":332,"type":20},40,[23],"This is a research study of an experimental drug called ACC-1898. ACC-1898 is an oral tyrosine kinase inhibitor (TKI) that blocks several proteins kinases which may help cancer cells grow and spread.\n\nThe purpose of this Phase 1 clinical trial is to find a safe dose of ACC-1898 and to understand how the body absorbs, distributes, and eliminates the drug (pharmacokinetics \u002F PK). The study will also look for early signs that ACC-1898 may slow or shrink tumors and explore possible biological markers related to drug activity.\n\nAdults with advanced or metastatic solid tumors who have no remaining standard treatment options may take part.\n\nAll participants will receive ACC-1898 tablets by mouth once daily in repeating 21-day cycles. Treatment may continue for up to two years if the cancer does not worsen and side effects are manageable.\n\nSafety information, laboratory results and imaging scans (CT or MRI) will be collected regularly.\n\nThe study will first test different dose levels (dose-escalation phase) and may later expand enrollment in selected tumor types once a recommended dose is found.",[336,148,337,338,339,340,144,28,179],"Hepatocellular Carcinoma","Thyroid Carcinoma, Medullary","Thyroid Carcinoma Primary Differentiated","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",[342,181,343,344,345,346,347,348,349],"Advanced Solid Tumors","Tyrosine Kinase Inhibitor","VEGFR","MET","RET","AXL","Multi-target TKI","ACC-1898","2025-11-25",{"date":352,"type":53},"2025-11-28",{"date":354,"type":20},"2026-01",{"date":356,"type":20},"2027-12",{"name":358,"class":165},"AccSalus Biosciences, Inc.",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":366,"sex":15,"minAge":16,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":61},"100606546","a-cell-free-dna-methylation-blood-based-test-for-biliary-tract-cancers-screening-100606546","NCT07176962","A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening","A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers","Inclusion Criteria Internal Training and Validation Cohorts\n\n* BTC patients\n\n  1. Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Other gastrointestinal malignancies (to exclude BTC non-specific signals)\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n* Non-cancer participants (benign biliary disease)\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n  4. Pathologically or clinically diagnosed benign biliary diseases, including cholecystitis, cholelithiasis, choledocholithiasis, adenomyomatosis, gallbladder polyps, xanthogranulomatous cholecystitis, or primary sclerosing cholangitis.\n\nExternal Validation Cohorts\n\n* BTC patients\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Imaging findings of malignant biliary stricture or mass, or serum CA19-9 \\> 100 U\u002FmL, highly suspicious for BTC, with planned surgery or biopsy for pathological confirmation.\n  3. Age 18-80 years (inclusive).\n  4. Able to provide required blood samples.\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Healthy volunteers\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n\nExclusion Criteria Training and Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders.\n  7. Known autoimmune diseases.\n  8. Concurrent other malignancies or multiple primary tumors.\n* Non-cancer participants\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders.\n  6. Known autoimmune diseases.\n  7. Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).\n\nExternal Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of or ongoing curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders or autoimmune diseases.\n  7. Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers.\n  8. Pathology confirmed benign disease after biopsy\u002Fsurgery.\n  9. Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site\u002Fevidence.\n  10. Special exclusion criteria:\n* Pathology confirmed precancerous lesions.\n* Any local\u002Fregional or systemic anti-tumor therapy (including surgery, radiotherapy, targeted therapy, or immunotherapy) prior to blood collection.\n* Healthy volunteers\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders or autoimmune diseases.\n  6. Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).",true,"80 Years",{"count":369,"type":20},1800,"Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.",[28,308,117,372,373,374],"Hilar Cholangiocarcinoma","Billiary Track Cancer","ctDNA",[376,377,378,373],"ctDNA methylation","Early diagnosis","Liquid biopsy","2025-09-10",{"date":381,"type":53},"2025-09-16",{"date":383,"type":53},"2020-01-01",{"date":385,"type":20},"2026-05-01",{"name":387,"class":60},"Yingbin Liu, MD, PhD, FACS",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":21,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":61},"100535024","robotic-assisted-contra-open-resection-for-suspected-or-confirmed-gallbladder-cancer-robocop-100535024","NCT06246448","Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)","Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial","ROBOCOP","Inclusion Criteria:\n\n* Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference.\n* Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist.\n\nExclusion Criteria:\n\n* Previous extensive surgery in the upper abdomen (for example open liver surgery)\n* Pregnancy\n* Intraoperative findings of dissemination (patient is then excluded after randomization)\n* Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization).\n* Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)",{"count":397,"type":20},94,[72],"The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting.\n\nThe primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.",[28],"2025-08-29",{"date":403,"type":53},"2025-09-05",{"date":405,"type":53},"2024-01-23",{"date":407,"type":20},"2027-03",{"name":409,"class":60},"Karolinska University Hospital",{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":21,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":436,"locationsCount":61},"100594878","phase-2-sequential-anti-angiogenic-therapy-after-immunotherapy-in-advanced-biliary-tract-cancer-100594878","NCT07025174","Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer","Evaluation of the Effect of Sequential Anti-angiogenic Therapy Following Immune Therapy Progression on Survival in Patients With Advanced Biliary Tract Malignancies: A Randomized, Multi-center, Exploratory Clinical Study","SAIB","Inclusion Criteria:\n\nAge 18-75 years at time of enrollment; Histologically or cytologically confirmed advanced or metastatic biliary tract adenocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma); Unresectable locally advanced or metastatic disease not amenable to curative treatment; At least one measurable lesion according to RECIST version 1.1 criteria; ECOG Performance Status 0-1; Life expectancy ≥ 12 weeks; No prior systemic chemotherapy, immunotherapy, or anti-angiogenic therapy for advanced disease (adjuvant therapy completed \\>6 months prior is allowed); Adequate bone marrow function: ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL; Adequate liver function: Total bilirubin ≤2.5×ULN, ALT and AST ≤3×ULN (or ≤5×ULN if liver metastases present); Adequate renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin; Signed informed consent.\n\nExclusion Criteria:\n\nMixed histology tumors or neuroendocrine components; Active central nervous system metastases (treated and stable metastases \\>4 weeks allowed); History of other malignancies within 5 years (except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ); Active autoimmune disease requiring systemic treatment; History of severe allergic reactions to monoclonal antibodies or study drug components; Uncontrolled hypertension (\\>140\u002F90 mmHg despite medication); Significant cardiovascular disease including unstable angina, myocardial infarction within 6 months, or NYHA Class III-IV heart failure; Active bleeding or bleeding tendency, thrombosis, or use of anticoagulants; Major surgery within 4 weeks or minor surgery within 2 weeks; Active infection requiring systemic treatment; Pregnancy or breastfeeding; HIV infection, active hepatitis B or C infection; Psychiatric illness that would limit compliance with study requirements.","75 Years",{"count":305,"type":20},[24],"Brief Summary:\n\nThis study is for patients with advanced biliary tract cancer (cancer of the bile ducts or gallbladder). The purpose is to find out if using anti-blood vessel formation drugs after immunotherapy treatment can help patients live longer without their cancer getting worse.\n\nWhat the study compares:\n\nControl group: Patients receive standard chemotherapy as first-line treatment, then chemotherapy plus anlotinib (an anti-blood vessel drug) if their cancer progresses Treatment group: Patients receive chemotherapy plus immunotherapy as first-line treatment, then the same second-line treatment as the control group if their cancer progresses\n\nWho can join:\n\nPatients aged 18-75 with advanced biliary tract cancer that has been confirmed by tissue testing, who have not received immunotherapy or anti-blood vessel drugs before, and who are in good enough health for treatment.\n\nWhat we want to learn:\n\nThe main goal is to see if patients who received immunotherapy first have better outcomes when they later receive anti-blood vessel treatment. We will measure how long patients live without their cancer getting worse during second-line treatment.\n\nStudy design:\n\nThis is a randomized study, meaning patients are assigned by chance to one of the two treatment groups. About 60 patients will participate across multiple hospitals in China. We will also collect blood and tissue samples to better understand how these treatments work.\n\nThe study will help doctors determine if this treatment sequence could become a new standard approach for patients with advanced biliary tract cancer.",[423,28,312,264],"Bile Duct Carcinoma",[425,426,427,428,429],"Biliary tract cancer","Immunotherapy","Anti-angiogenic therapy","Anlotinib","Sequential therapy","2025-06-10",{"date":432,"type":53},"2025-06-17",{"date":434,"type":53},"2025-06-01",{"date":234,"type":20},{"name":437,"class":60},"First Affiliated Hospital of Zhejiang University",{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":21,"phases":448,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":61},"100532574","phase-2-radiation-therapy-in-unresectable-gall-bladder-cancer-100532574","NCT06214572","Radiation Therapy in Unresectable Gall Bladder Cancer","Systemic Therapy With or Without Radiation Therapy in Unresectable Nonmetastatic Gall Bladder Carcinoma: Open Label, Parallel Arm, Phase 2\u002F3 Integrated Randomized Clinical Trial","RUGB","Inclusion Criteria:\n\n* Histologically proven (biopsy\u002Fcytology) adenocarcinoma of gall bladder. Gall bladder neck primaries with hilar block mimicking hilar cholangiocarcinoma will also be included.\n* Non metastatic at presentation as determined using cross sectional imaging and diagnostic laparoscopy if done as a part of standard work up recommended in the joint clinic.\n* Locally advanced disease with one or more of the following\n* Extensive liver infiltration not amenable for surgery but feasible for safe radiation delivery (Liver minus gross tumor volume at least 700cc)\n* Vascular involvement: encasement (\\>180-degree angle) of one of the vessels: Hepatic artery, main portal vein, right or left portal vein\n* Obstructive jaundice with hilar involvement (type 2 non communicating block and higher blocks as per Bismuth-Corlette classification)\n* Stable disease or partial response (RECIST 1.1) after initial 3 months of Gemcitabine based chemotherapy\n* More than 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 fit for chemotherapy\n* Normal hematological and renal and hepatic functions allowing safe delivery of chemotherapy\n* Hematological- Hb\\> 80 g\u002FL, ANC ≥ 1.5 x 109\u002FL, platelets ≥ 100 x 109\u002FL.\n* Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST\u002FALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g\u002FL\n* Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \\>= 50 mL\u002Fmin\n\nExclusion Criteria:\n\n* Patients with distant metastasis (including nonregional lymph nodes metastasis) will be excluded.\n* Prior abdominal therapeutic radiation\n* Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix\n* Pregnancy\u002FLactating women",{"count":447,"type":20},249,[24,449],"PHASE3","The goal of this clinical trial is to compare two treatment regimes, namely, systemic therapy (chemotherapy and\u002For immunotherapy) alone vs. systemic therapy and radiation therapy in patients with inoperable but localized gallbladder cancer. The main questions it aims to answer are:\n\n* Whether adding radiation therapy to systemic therapy improves overall survival?\n* What are the effects on other endpoints like cancer-free intervals, side effects, and quality of life? Participants will be randomly assigned to one of the two treatment regimes mentioned earlier by a computer-based program. Researchers will compare survival and quality of life outcomes between the two groups.",[28],[425,28,453,454],"Radiation therapy","Unresectable","2025-04-08",{"date":457,"type":53},"2025-04-11",{"date":459,"type":53},"2024-03-07",{"date":461,"type":20},"2029-07-21",{"name":323,"class":60},{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":21,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":61},"100581590","phase-2-phase-ii-clinical-study-of-gemox-hepatic-arterial-infusion-combined-with-lenvatinib-and-toripalimab-for-advanced-and-unresectable-intrahepatic-cholangiocarcinoma-and-gallbladder-cancer-100581590","NCT06852287","Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","GOLD-HAIC","Inclusion Criteria\n\n1. Age 18 or above\n2. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer\n3. A tumor that cannot be removed by three independent surgeons.\n4. Expected lifespan ≥ 12 weeks\n5. ECOG PS score 0-1 points\n6. The patient voluntarily participates and signs an informed consent form;\n7. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.\n\nExclusion criteria:\n\n1. Use any systemic research anti-cancer drugs\n2. Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)\n3. Asthma requires the use of bronchodilators for medical intervention\n4. Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection\n5. Clinical symptoms or uncontrolled heart disease\n6. Severe infection within 4 weeks before the first use of medication\n7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n8. Vaccination with attenuated live vaccine within 4 weeks before treatment\n9. Other systemic malignant tumors in the past 5 years",{"count":471,"type":20},33,[24],"For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects.\n\nThis study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.",[308,28],[476],"GemOX, Lenvatinib, Toripalimab","2025-02-25",{"date":479,"type":53},"2025-02-28",{"date":481,"type":53},"2024-09-01",{"date":483,"type":20},"2026-09-01",{"name":485,"class":60},"Tianjin Medical University Cancer Institute and Hospital"]