[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gallbladder-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gallbladder-carcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,58,104,133,176],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100642684","phase-1-dual-target-her2cea-car-nk-cells-in-advanced-biliary-tract-cancer-100642684",false,"NCT07641036","Dual-Target HER2\u002FCEA CAR-NK Cells in Advanced Biliary Tract Cancer","A Phase 1\u002F2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2\u002FCEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers","DUET-BTC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\n* Disease progression after at least 1 prior gemcitabine\u002Fplatinum-containing regimen in the advanced setting; prior durvalumab and prior HER2-targeted therapy are allowed.\n* Central biomarker confirmation of HER2 positivity (IHC 3+ or IHC 2+\u002FISH+ or ERBB2 amplification) and CEACAM5\u002FCEA positivity (membranous expression in \\>=20% of viable tumor cells by IHC).\n* At least 1 measurable lesion according to RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol.\n* Resolved biliary obstruction or stable internal\u002Fexternal drainage for \\>=7 days before lymphodepletion, with no active cholangitis.\n* Life expectancy \\>=12 weeks.\n* Willingness to provide archival or fresh tumor tissue and serial blood samples for central biomarker testing and correlative studies.\n* Agreement to use protocol-specified contraception\n\nExclusion Criteria:\n\n* Prior HER2-directed or CEA-directed gene-modified cell therapy.\n* Untreated or unstable CNS metastases or leptomeningeal disease.\n* Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection.\n* Ongoing systemic immunosuppression greater than 10 mg\u002Fday prednisone equivalent within 7 days before lymphodepletion.\n* Clinically significant interstitial lung disease, uncontrolled heart failure, unstable arrhythmia, or recent myocardial infarction.\n* Child-Pugh B or C liver disease, hepatic encephalopathy, or clinically significant refractory ascites.\n* Prior allogeneic solid organ transplant or allogeneic stemcell transplant.\n* Active autoimmune disease requiring systemic therapy within the previous 2 years.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This example phase 1\u002F2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.",[28,29,30,31,32],"Cholangiocarcinoma","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Carcinoma","Biliary Tract Cancer",[34,35,36,37,38,39,40,41,42,43,44],"CAR-NK","dual-target cell therapy","HER2","ERBB2","CEA","CEACAM5","cholangiocarcinoma","biliary tract cancer","allogeneic","off-the-shelf","adoptive cell therapy","RECRUITING","2026-06-06",{"date":48,"type":49},"2026-06-11","ACTUAL",{"date":51,"type":49},"2026-03-02",{"date":53,"type":21},"2028-10-17",{"name":55,"class":56},"Beijing Biotech","INDUSTRY",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":78,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":57},"100635757","outcomes-after-liver-and-biliary-resection-at-a-high-volume-center-100635757","NCT07556835","Outcomes After Liver and Biliary Resection at a High-Volume Center","Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia","BILIVER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients undergoing liver resection and\u002For biliary resection at San Jacopo Hospital, Pistoia\n* Diagnosis of benign or malignant hepatobiliary disease\n* Availability of clinical, surgical, and follow-up data\n* For the prospective cohort, provision of written informed consent when required according to local regulations\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* No liver or biliary resection performed\n* Biopsy only without resection\n* Refusal or unavailability of consent for the prospective cohort when consent is required",{"count":67,"type":21},1000,"OBSERVATIONAL","The goal of this observational study is to evaluate clinical and oncologic outcomes in adult patients undergoing liver and\u002For biliary resection for benign and malignant diseases.\n\nThis study evaluates postoperative morbidity and mortality within 90 days after surgery, as well as overall survival and disease-free survival in patients with malignant disease.\n\nParticipants will:\n\n* undergo standard surgical and perioperative management according to routine clinical practice\n* have clinical, surgical, and follow-up data collected from institutional medical records\n* be followed for postoperative outcomes and long-term oncologic outcomes up to 5 years",[71,72,28,73,74,75,76,77,31],"Liver Neoplasms","Hepatobiliary Diseases","Hepatocellular Carcinoma","Liver Metastases From Colorectal Cancer","Liver Metastases","Biliary Tract Diseases","Benign Liver Disease",[79,80,81,82,83,84,85,86,87,88,89,90,91,92,28],"Hepatobiliary surgery","Liver resection","Biliary resection","Hepatectomy","Postoperative complications","Postoperative mortality","Clavien-Dindo classification","Overall survival","Disease-free survival","Surgical outcomes","Observational study","Ambispective cohort","CRLM","HCC","NOT_YET_RECRUITING","2026-04-22",{"date":96,"type":49},"2026-04-29",{"date":98,"type":21},"2026-04",{"date":100,"type":21},"2036-12",{"name":102,"class":103},"Azienda USL Toscana Centro","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100604217","phase-2-trifluridinetipiracil--oxaliplatin-in-participants-with-advanced-or-metastatic-biliary-tract-cancer-100604217","NCT07146646","Trifluridine\u002FTipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer","A Phase II Trial of Trifluridine\u002FTipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic.\n* Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.\n* Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study.\n* Age \\>18 years on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of FTD\u002FTPI in individuals ≤18 years of age, children are excluded from this study.\n* Performance status: ECOG performance status of 0 or 1.\n* At least one index lesion is measurable based on RECIST 1.1.\n* Participants must have organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelet count ≥75,000\u002FmcL\n  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels \\>1.5 x ULN\n  * Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin for participants with creatinine levels \\>1.5 x ULN (Cockcroft-Gault method)\n* Participants must have recovered adequately from any major surgery, prior to starting therapy.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Agree to use adequate method of contraception.\n\nExclusion Criteria:\n\n* Participants receiving any other investigational agents.\n* Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).\n* Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.\n* Receiving systemic steroid therapy (\\>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Prior treatment with FTD\u002FTPI or oxaliplatin.\n* Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has already undergone potentially curative therapy.\n* Known central nervous system metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.\n* Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\\> 10 mg\u002Fday or equivalent of prednisone) or immunosuppressive agents. (thyroid disease and diabetes are allowed)\n* Interstitial lung disease or active, non-infectious pneumonitis.\n* Active infection requiring systemic antibiotics.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the individual's participation for the full duration of the trial, or is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.\n* Participants with uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\u002Fsubstance abuse disorders that would limit compliance with study requirements.\n* Participants pregnant or breastfeeding expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment. Pregnant or breastfeeding women are excluded from this study because it is unknown if the combination of FTD\u002FTPI and oxaliplatin create the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug combination, breastfeeding should be discontinued if the mother is enrolled on this trial.","19 Years",{"count":113,"type":21},27,[25],"Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine\u002Ftipiracil (FTD\u002FTPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD\u002FTPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).",[32,117,28,118,31],"Biliary Tract Neoplasms","Gallbladder Cancer",[120,121,122],"Trifluridine\u002Ftipiracil","FTD\u002FTPI","Oxaliplatin","2026-02-17",{"date":125,"type":49},"2026-02-19",{"date":127,"type":49},"2025-12-01",{"date":129,"type":21},"2027-04",{"name":131,"class":103},"Case Comprehensive Cancer Center",2,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":161,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":57},"100571099","target-specific-immunopet-imaging-of-digestive-system-carcinoma-100571099","NCT06715839","Target-specific immunoPET Imaging of Digestive System Carcinoma","Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma","Inclusion Criteria:\n\n1. Aged 18-75 years old and of either sex；\n2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;\n3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Pregnancy；\n2. Severe hepatic and renal insufficiency;\n3. History of serious surgery in the last month;\n4. Allergic to antibody or single-domain antibody radiopharmaceuticals.","75 Years",{"count":142,"type":21},400,[144],"NA","The aim of this study is to establish and optimize the target-specific PET\u002FCT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.",[147,148,149,150,151,152,153,154,155,156,157,31,158,159,160],"Malignancy","Digestive Cancer","Digestive System Neoplasm","Digestive System Carcinoma","Digestive System Cancer","Liver Cancer","Stomach Cancer","Colon Cancer","Rectum Cancer","Pancreatic Cancer","Esophagus Cancer","Small Intestine Cancer","Appendix Cancer","Bile Duct Carcinoma",[162,163,164,165,166],"human epidermal growth factor receptor 2 (HER2)","Trophoblast cell surface antigen 2 (TROP2)","Glypican-3 (GPC3)","Glycoprotein A33 (gpA33)","Nectin cell adhesion molecule-4 (Nectin-4)","2025-12-25",{"date":169,"type":49},"2025-12-31",{"date":171,"type":49},"2024-12-04",{"date":173,"type":21},"2027-09",{"name":175,"class":103},"RenJi Hospital",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":132},"100376606","phase-2-target-therapy-with-gemox-in-recectable-gallbladder-carcinoma-patients-monitored-by-ctdna-100376606","NCT04183712","Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA","A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.","Inclusion Criteria:\n\n* Chinese#\n* Stable vital signs, ECOG:0-1;\n* Patients have a diagnosis of resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery.\n* Adequate fresh tumor tissue for genome sequencing and immunohistochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components\n* Life expectancy of more than 18 weeks;\n* T stage≥ T2 or histopathological lymph node positive according to AJCC (8th edition) staging.\n* Adequate hepatic, hematologic and renal functions(ALT≤5×upper limit of normal (ULN), AST≤5×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10\\^9\u002FL, neutrophils≥1.5×10\\^9\u002FL, platelets≥75×10\\^9\u002FL , hemoglobin ≥ 90g\u002FL, creatinine clearance rate≥60ml\u002Fmin;\n* Volunteer for this study, have written informed consent and have good Patient compliance;\n* Female patients of childbearing potential and their mates agree to avoid pregnancy.\n\nExclusion Criteria:\n\n* Have received following treatment before this study: a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions have been treated by irradiation; c. participate in other therapeutic or interventional clinical trials.\n* History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;\n* Have serious concurrent illness including, but not limited to uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure \\>21.3 Kpa or diastolic blood pressure \\>13.3 Kpa);\n* Have ongoing or active serious infection;\n* Have uncontrolled diabetes mellitus;\n* Psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;\n* Active autoimmune diseases require long-term use of steroids or received allotransplantation\n* Other serious illness considered not suitable for this study by investigators.","80 Years",{"count":185,"type":21},102,[25],"The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in recectable gallbladder carcinoma patients monitored by ctDNA.",[31],"2024-10-13",{"date":191,"type":49},"2024-10-16",{"date":193,"type":49},"2020-06-01",{"date":195,"type":21},"2025-12",{"name":197,"class":103},"Shanghai Jiao Tong University School of Medicine"]