[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"btc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:btc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":24,"conditions":25,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100638748","surgical-total-clearance-versus-extrahepatic-bile-duct-preservation-for-biliary-tract-malignancies-a-single-center-randomized-two-arm-prospective-phase-ii-clinical-trial-100638748",false,"NCT07609641","Surgical Total Clearance Versus Extrahepatic Bile Duct Preservation for Biliary Tract Malignancies: A Single-Center, Randomized, Two-Arm, Prospective Phase II Clinical Trial","Inclusion Criteria:\n\n* Age 18 years or older, regardless of gender.\n\nVoluntary participation with full informed consent; signed written informed consent form; good compliance.\n\nHistologically or cytologically confirmed cholangiocarcinoma (CCA).\n\nGallbladder cancer or intrahepatic cholangiocarcinoma with preoperative lymph node metastasis.\n\nNo prior systemic chemotherapy, immunotherapy, targeted therapy, or local treatment for CCA (including but not limited to transarterial chemoembolization, arterial embolization, arterial infusion chemotherapy, and radioactive particle embolization).\n\nAt least one measurable lesion according to RECIST v1.1.\n\nChild-Pugh class A liver function, and no history of hepatic encephalopathy.\n\nEastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.\n\nLife expectancy ≥ 12 weeks.\n\nAdequate organ function meeting the following requirements (no blood transfusion, blood products, hematopoietic growth factors, or other medications to correct blood counts within 14 days prior to randomization):\n\nWhite blood cell count ≥ 4.0 × 10⁹\u002FL;\n\nAbsolute neutrophil count ≥ 1.5 × 10⁹\u002FL;\n\nPlatelet count ≥ 90 × 10⁹\u002FL;\n\nHemoglobin ≥ 90 g\u002FL;\n\nSerum albumin ≥ 30 g\u002FL;\n\nSerum total bilirubin ≤ 2 × upper limit of normal (ULN); any biliary obstruction must be resolved before randomization;\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n\nCreatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n\nInternational normalized ratio (INR) ≤ 2 and prothrombin time (PT) prolonged ≤ 3 seconds above the ULN.\n\nFor active hepatitis B, effective antiviral therapy (per local standard of care, e.g., entecavir or tenofovir) is required, with HBV DNA \\\u003C 2000 IU\u002FmL or a ≥ 10-fold decrease in HBV DNA after antiviral treatment; patients must agree to continue effective anti-HBV therapy throughout the study period.\n\nWithin 7 days prior to randomization, women of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception during the study treatment period and for 6 months after the last dose. In this protocol, a woman of childbearing potential is defined as a sexually mature woman who: 1) has not undergone hysterectomy or bilateral oophorectomy; 2) has not been naturally postmenopausal for at least 24 consecutive months (amenorrhea following cancer therapy does not rule out fertility) (i.e., has had menses at any time in the preceding 24 consecutive months). Male patients with female partners of childbearing potential must agree to use effective contraception during the study treatment period and for 5 months after the last dose.\n\nExclusion Criteria:\n\n* Histopathologically or cytologically confirmed hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.\n\nOther malignancy within 5 years, except for cured localized tumors, including non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.\n\nRadiotherapy for CCA within 4 weeks prior to randomization; major surgery (excluding diagnostic biopsy) within 4 weeks prior to randomization.\n\nHistory of severe cardiovascular or cerebrovascular disease:\n\nNew York Heart Association (NYHA) class II or greater congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident within 12 months prior to randomization;\n\nLeft ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography;\n\nCorrected QT interval (QTc) \\> 480 ms (calculated using the Fridericia method; if QTc is abnormal, it may be measured three times consecutively at 2-minute intervals, and the average taken);\n\nPoorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, based on the average of ≥ 2 readings);\n\nPrior hypertensive crisis or hypertensive encephalopathy.\n\nEvidence of significant bleeding\u002Fcoagulation disorder or bleeding tendency:\n\nClinically significant hemoptysis or tumor bleeding of any cause within 4 weeks prior to randomization;\n\nPrior tumor rupture (unless surgically treated);\n\nThrombotic or embolic event within 6 months prior to randomization;\n\nTherapeutic anticoagulation within 2 weeks prior to randomization (except for low-molecular-weight heparin);\n\nNeed for antiplatelet therapy;\n\nUse of aspirin (\\> 325 mg\u002Fday), clopidogrel (\\> 75 mg\u002Fday), dipyridamole, ticlopidine, or cilostazol within 10 days prior to randomization.\n\nKnown central nervous system metastasis and\u002For meningeal metastasis (including dural and leptomeningeal metastasis).\n\nAny other condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.","ALL","18 Years","80 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","When lymph node dissection of stations 12 and 13 is performed, resecting the bile duct from the superior portion of the pancreas to the confluence of the right and left hepatic ducts allows complete removal of the station 12 and 13 lymph nodes. Preserving the bile duct from the superior pancreas to the hepatic confluence, however, makes a skeletonizing dissection of the duct impossible in order to safeguard the biliary blood supply, inevitably leaving behind a small amount of periductal lymphoid tissue. This results in incomplete lymph node clearance, which may increase the risk of postoperative recurrence and reduce the R0 resection rate.\n\nThis study aims to investigate the lymph node dissection approach for surgically resected cholangiocarcinoma following induction therapy, to establish criteria for evaluating surgical indications, and to provide a basis for surgical treatment strategies in patients with cholangiocarcinoma.",[26],"BTC",[26],"RECRUITING","2026-05-20",{"date":31,"type":32},"2026-05-27","ACTUAL",{"date":34,"type":32},"2025-10-20",{"date":36,"type":20},"2027-12-31",{"name":38,"class":39},"Tianjin Medical University Cancer Institute and Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100613190","phase-2-iparomlimab-and-tuvonralimab-injection-combined-with-gemox-and-lenvatinib-as-conversion-therapy-for-initially-potentially-resectable-intrahepatic-cholangiocarcinoma-and-gallbladder-cancer-100613190","NCT07263360","Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","A Single-arm, Single-center Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Histologically or cytologically confirmed diagnosis of locally advanced or potentially resectable intrahepatic cholangiocarcinoma or gallbladder cancer, defined as T2b-T4 or N1 M0 according to the AJCC 8th edition.\n* Expected life expectancy ≥ 12 weeks.\n* No prior systemic treatment for biliary tract cancer before the first dose of study medication.\n* At least one measurable lesion as defined by RECIST 1.1 criteria.\n* ECOG Performance Status of 0 or 1.\n* Adequate organ function, without severe dysfunction of the hematologic, cardiac, pulmonary, hepatic, renal, bone marrow, or immune systems.\n* Laboratory tests meeting the following requirements: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. For men, they must be surgically sterile or agree to use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug.\n* Patient voluntarily participates and provides written informed consent.\n* Good compliance is anticipated, allowing for efficacy and adverse event follow-up per the protocol.\n\nExclusion Criteria:\n\n* The subject has received any prior antitumor therapy or any investigational anticancer agents.\n* Presence of any active autoimmune disease or a history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[may be enrolled if stable on hormone replacement therapy\\]). Patients with childhood asthma that has completely resolved in adulthood without any intervention, or vitiligo, may be enrolled. Patients requiring medical intervention with bronchodilators are not eligible.\n* Known congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection.\n* Uncontrolled cardiac clinical symptoms or diseases, e.g., NYHA Class II or above heart failure, unstable angina, myocardial infarction within 1 year, or patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n* Severe concurrent infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever \\>38.5°C during screening\u002Fprior to the first dose.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period.\n* History of or concurrent other malignant tumors within the past 5 years (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ovarian cancer).\n* Gastrointestinal bleeding event or active hemoptysis within 28 days prior to the first dose.\n* Gastric or esophageal varices requiring treatment.\n* Active malignant tumors within 36 months prior to enrollment.\n* Known allergy to any of the investigational drug components.\n* Poorly controlled psychiatric disorder.\n* Presence of superior mesenteric vein tumor thrombus, metastasis to group 16 lymph nodes, or distant metastasis to other organs \u002F biological factors: peritoneal metastasis, direct invasion to adjacent organs, etc. \u002F involvement of organs (pancreas, stomach, duodenum, colon) that cannot be resected en bloc.\n* Any other condition deemed by the investigator as unsuitable for enrollment. This includes, but is not limited to, pre-existing central nervous system metastases, severe laboratory abnormalities, or familial\u002Fsocial factors that could compromise the subject's safety, or data\u002Fsample collection.\n* Patients with extensive liver metastases involving the entire liver.",{"count":49,"type":20},29,[51],"PHASE2","The primary objective is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1\u002FCTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer.",[26],[55,56,57],"lparomlimab and Tuvonralimab injection","GemOX","Lenvatinib","NOT_YET_RECRUITING","2025-11-23",{"date":61,"type":32},"2025-12-04",{"date":63,"type":20},"2026-02-01",{"date":65,"type":20},"2029-12-31",{"name":38,"class":39}]