[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608974":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":75,"collaborators":78,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":31,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":31,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":31,"overallStatus":109,"whyStopped":31,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Medication Group","PLACEBO_COMPARATOR","Upon randomization, patients will continue to receive the GOLP regimen for up to 8 cycles, followed by maintenance therapy with lenvatinib plus toripalimab for one year, until disease progression, withdrawal from the study, or the occurrence of intolerable toxicity.",[13],"Drug: GOLP regimen",{"label":15,"type":16,"description":17,"interventionNames":18},"Surgery Group","EXPERIMENTAL","Surgical resection is to be performed within 2-4 weeks after randomization, followed by adjuvant therapy with capecitabine at a dose of 1250 mg\u002Fm² twice daily, administered orally for eight cycles (each cycle consists of 14 days of medication followed by a 7-day rest period, constituting a 3-week treatment cycle).",[19],"Procedure: Surgery",{"label":21,"type":16,"description":22,"interventionNames":23},"TDTP Group","Following randomization, patients will be evaluated using the TDTP-RECIST system. Those who meet the predetermined cutoff value (63%) will proceed to surgical resection. Patients not meeting the cutoff value will continue the GOLP regimen for up to 8 cycles, during which those who subsequently meet the cutoff value will undergo surgery. Postoperative adjuvant therapy will consist of capecitabine (1250 mg\u002Fm², BID, orally) for eight cycles (each cycle: 14 days on, 7 days off, constituting a 3-week cycle). Patients who do not meet the cutoff value after 8 cycles of GOLP therapy will receive maintenance therapy with lenvatinib plus toripalimab for up to one year or until intolerable toxicity occurs.",[24],"Diagnostic Test: TDTP-RECIST",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","GOLP regimen","PD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"PROCEDURE","Surgery","R0 resection",[15],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"DIAGNOSTIC_TEST","TDTP-RECIST","Treatment selection between continued GOLP therapy and surgical R0 resection based on TDTP-RECIST criteria.",[21],[43],{"name":44,"affiliation":5,"role":45},"Jia Fan, MD&PhD","STUDY_CHAIR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":31,"email":51},"Xiao-Yong Huang, MD","CONTACT","+8615021519215","huang.xiaoyong@zs-hospital.sh.cn",{"name":53,"role":49,"phone":54,"phoneExt":31,"email":55},"Guo-Ming Shi, MD","+8613916969578","shi.guoming@zs-hospital.sh.cn",[57],{"facility":58,"status":31,"city":59,"state":31,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Zhongshan hospital, Shanghai","Shanghai","200032","China","CN",{"type":64,"coordinates":65},"Point",[66,67],121.45806,31.22222,{"lat":67,"lon":66},[70,72,73],{"name":71,"role":49,"phone":50,"phoneExt":31,"email":51},"Xiao-yong Huang, MD",{"name":53,"role":49,"phone":54,"phoneExt":31,"email":55},{"name":44,"role":74,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"type":74,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Jia Fan","Professor",[79,81,83,85],{"name":80,"class":6},"Shanghai Geriatric Medical Center",{"name":82,"class":6},"Shanghai Jiao Tong University Affiliated Sixth People's Hospital",{"name":84,"class":6},"Shanghai 10th People's Hospital",{"name":86,"class":87},"Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University","UNKNOWN","100608974","a-randomized-trial-of-surgical-decision-making-guided-by-tdtp-recist-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":99,"type":100},270,"ESTIMATED","INTERVENTIONAL",[103],"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).",[106,107,39,108],"Intrahepatic Cholangiocarcinoma (Icc)","Conversion Therapy","GOLP Regimen","NOT_YET_RECRUITING","2025-09-28",{"date":112,"type":113},"2025-10-06","ACTUAL",{"date":115,"type":100},"2025-12-01",{"date":117,"type":100},"2028-12-31",{"name":5,"class":6},1]