[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,80,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100523866","locally-ablative-therapy-for-oligo-progressive-gastrointestinal-malignancies-livelong-100523866",false,"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.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28,29,30,31,32,33],"Small Bowel Cancer","Colorectal Cancer","Appendiceal Cancer","Biliary Cancer","Gall Bladder Cancer","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Oligoprogressive","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2023-10-05",{"date":42,"type":20},"2039-09-15",{"name":44,"class":45},"University of California, Davis","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":46},"100504526","phase-1-a-study-of-cdx-1140-a-cd40-agonist-in-combination-with-capecitabine-and-oxaliplatin-capox-and-keytruda-in-subjects-with-biliary-tract-carcinoma-btc-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.","120 Years",{"count":56,"type":20},60,[58,59],"PHASE1","PHASE2","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.",[29,62,63],"Bile Duct Cancer","Cancer of the Bile Duct",[65,66,67,68,69],"Immunotherapy","Pembrolizumab","CAPOX","CDX-1140","CD40 agonist","2026-03-21",{"date":72,"type":38},"2026-03-24",{"date":74,"type":38},"2024-05-08",{"date":76,"type":20},"2042-06-01",{"name":78,"class":79},"National Cancer Institute (NCI)","NIH",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":102,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":46},"100579047","phase-1-phase-iii-clinical-study-to-evaluate-vb15010-tablets-in-patients-with-advanced-solid-tumors-100579047","NCT06819215","Phase I\u002FII Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors","Phase I\u002FII Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 at the time of screening;\n* Histological or cytological confirmation of advanced malignancy ;\n* Progressive cancer at the time of study entry;\n* Adequate organ and marrow function as defined by the protocol;\n* Homologous recombination repair gene mutation.\n\nExclusion Criteria:\n\n* Major surgery within 4 weeks of the first dose of study treatment.\n* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \\>10mg prednisone\u002Fday or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukaemia (AML).","75 Years",{"count":89,"type":20},188,[58,59],"This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.",[93,94,95,96,97,98,99,100,101,29,27],"Cancer","Neoplasms","Neoplasms, Breast","Tumor","PARP","Ovarian Neoplasms","Prostatic Cancer","Pancreatic Cancer","Breast Cancer",[103,97,104,99,105,106,29],"VB15010","Ovarian cancer","Pancreatic cancer","Breast cancer","2025-02-04",{"date":109,"type":38},"2025-02-11",{"date":111,"type":38},"2024-10-30",{"date":113,"type":20},"2026-03-30",{"name":115,"class":116},"Zhejiang Yangli Pharmaceutical Technology Co., Ltd.","INDUSTRY",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":46},"100479040","pre--and-post-operative-teg-indices-in-patients-with-or-without-adenocarcinoma-undergoing-surgical-resection-100479040","NCT05517811","Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection","Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG","TEG","Inclusion Criteria:\n\n* new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study\n* 18 Years and older\n\nExclusion Criteria:\n\n* Under 18 years old\n* prisoners\n* those unable to provide informed consent\n* pregnant women\n* and those undergoing emergent or urgent operative intervention at the time of diagnosis",true,"99 Years",{"count":128,"type":20},400,"OBSERVATIONAL","The investigators hypothesize that abnormalities in thromboelastography (TEG) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. The investigators further hypothesize that there is histologic pathology correlates to pre-operative TEG abnormalities, and that it identifies patients with virulent tumor biology.",[132,133,27,134,135,136,29],"Liver Cancer","Esophageal Cancer","Lung Adenocarcinoma","Control","Pancreas Cancer","2025-01-27",{"date":139,"type":38},"2025-01-28",{"date":141,"type":38},"2022-06-26",{"date":143,"type":20},"2028-07-31",{"name":145,"class":45},"University of Colorado, Denver"]