[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tdtp-recist\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tdtp-recist":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100608974",false,"NCT07208526","A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST","A Multicenter Randomized Controlled Study on Surgical Decision-Making Guided by the TDTP-RECIST Evaluation System for Locally Advanced Intrahepatic Cholangiocarcinoma Following GOLP Conversion Therapy","Inclusion Criteria:\n\n\\-\n\nSubjects eligible to participate in this study must meet all of the following criteria:\n\n1. Male or female aged 18-75 years;\n2. Patients must provide signed informed consent prior to enrollment, demonstrating the ability to understand and willingness to sign the written informed consent form;\n3. Pathologically confirmed diagnosis of intrahepatic cholangiocarcinoma;\n4. Locally advanced disease, failure to achieve R0 resection, and absence of distant metastasis;\n5. At least one measurable lesion;\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0;\n7. Child-Pugh class A liver function;\n\nExclusion Criteria:\n\n\\-\n\nSubjects who meet any of the following exclusion criteria are not permitted to enroll in this study:\n\n1. Pathologically diagnosed hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma, or other non-cholangiocarcinoma malignant components;\n2. Patients with postoperative recurrence, or those who have previously received PD-1\u002FPD-L1 antibodies, CTLA-4 antibodies, lenvatinib, or chemotherapy;\n3. History or current diagnosis of other malignancies;\n4. Active tuberculosis infection;\n5. Active, known, or suspected autoimmune disease;\n6. History of interstitial lung disease, or non-infectious pneumonitis requiring steroid treatment;\n7. Significant clinically significant bleeding symptoms within 3 months prior to enrollment, or clear bleeding tendency;\n8. Suspected allergy to the investigational drug(s).","ALL","18 Years","75 Years",{"count":19,"type":20},270,"ESTIMATED","INTERVENTIONAL",[23],"NA","This project aims to conduct a prospective, multicenter, randomized controlled clinical trial. The study plans to enroll 270 patients with locally advanced iCCA who have successfully undergone GOLP conversion therapy. Participants will be randomized at a 1:2:2 ratio into three arms: Control Arm (continued medication), Direct Surgery Arm, and TDTP-RECIST Assessment Arm. The primary endpoint is Overall Survival (OS).",[26,27,28,29],"Intrahepatic Cholangiocarcinoma (Icc)","Conversion Therapy","TDTP-RECIST","GOLP Regimen","NOT_YET_RECRUITING","2025-09-28",{"date":33,"type":34},"2025-10-06","ACTUAL",{"date":36,"type":20},"2025-12-01",{"date":38,"type":20},"2028-12-31",{"name":40,"class":41},"Shanghai Zhongshan Hospital","OTHER",""]