[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645572":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":52,"centralContacts":62,"locations":71,"responsibleParty":327,"collaborators":30,"id":330,"slug":331,"hasResults":332,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":332,"sex":338,"minAge":339,"maxAge":30,"enrollmentInfo":340,"targetDuration":30,"studyType":343,"phases":344,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":353,"whyStopped":30,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":363},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"TACE Plus Tislelizumab and Lenvatinib","EXPERIMENTAL","Participants will receive tislelizumab 200 mg intravenously every 3 weeks and oral lenvatinib once daily at a starting dose of 12 mg for body weight ≥60 kg or 8 mg for body weight \\\u003C60 kg. TACE will be performed after initiation of lenvatinib and may be repeated based on radiologic response, residual viable tumor, liver function, and investigator assessment. Both conventional TACE (cTACE) and drug-eluting beads TACE are allowed, and hepatic artery infusion chemotherapy may be added at investigator's discretion. Treatment will continue until clinical progression, radiologic progressive disease according to RECIST v1.1, completion of 2 years of immunotherapy, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria.",[13,14,15,16],"Drug: Tislelizumab","Drug: Lenvatinib","Procedure: Transcatheter Arterial Chemoembolization","Procedure: Hepatic Arterial Infusion Chemotherapy",{"label":18,"type":19,"description":20,"interventionNames":21},"Gemcitabine-Cisplatin Plus Tislelizumab","ACTIVE_COMPARATOR","Participants will receive cisplatin 25 mg\u002Fm² on Day 1 and Day 8, gemcitabine 1000 mg\u002Fm² on Days 1 and 8, and tislelizumab 200 mg on Day 1 of each 3-week cycle for up to 8 cycles. After completion of gemcitabine-cisplatin treatment, participants will continue tislelizumab 200 mg intravenously every 3 weeks. Treatment will continue until clinical progression, radiologic progressive disease according to RECIST v1.1, completion of 2 years of immunotherapy, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria.",[22,23,13],"Drug: Gemcitabine","Drug: Cisplatin",[25,31,35,39,43,48],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Gemcitabine","Gemcitabine 1000 mg\u002Fm² intravenously on Days 1 and 8 of each 21-day cycle, up to 8 cycles.",[18],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Cisplatin","Cisplatin 25 mg\u002Fm² intravenously on Day 1 and Day 8 of each 21-day cycle, up to 8 cycles.",[18],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Tislelizumab","Tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle, followed by maintenance tislelizumab every 3 weeks.",[18,9],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"Lenvatinib","Oral lenvatinib once daily, 12 mg for participants with body weight ≥60 kg or 8 mg for participants with body weight \\\u003C60 kg, with dose modification according to toxicity.",[9],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"PROCEDURE","Transcatheter Arterial Chemoembolization","Conventional TACE or drug-eluting bead TACE are allowed. TACE may be repeated based on imaging assessment every 6 weeks ±7 days and investigator judgment.",[9],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"Hepatic Arterial Infusion Chemotherapy","Optional hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to protocol-defined dose ranges.",[9],[53,56,59],{"name":54,"affiliation":5,"role":55},"Gaojun Teng, MD","PRINCIPAL_INVESTIGATOR",{"name":57,"affiliation":58,"role":55},"Min Kuang, MD","First Affiliated Hospital, Sun Yat-Sen University",{"name":60,"affiliation":61,"role":55},"Jiansong Ji, MD","The Central Hospital of Lishui City",[63,67],{"name":54,"role":64,"phone":65,"phoneExt":30,"email":66},"CONTACT","+86 13805171500","gjteng@seu.edu.cn",{"name":68,"role":64,"phone":69,"phoneExt":30,"email":70},"Binyan Zhong, MD","+86 15850522044","byzhongir@sina.com",[72,96,107,118,129,140,154,169,184,195,210,224,239,254,271,285,302,316],{"facility":73,"status":30,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","Guangdong","510060","China","CN",{"type":80,"coordinates":81},"Point",[82,83],113.25,23.11667,{"lat":83,"lon":82},[86,90,93],{"name":87,"role":64,"phone":88,"phoneExt":30,"email":89},"Ming Kuang","020-87755766","kuangm@mail.sysu.edu.cn",{"name":91,"role":64,"phone":30,"phoneExt":30,"email":92},"Zhenwei Peng","pzhenw@mail.sysu.edu.cn",{"name":94,"role":95,"phone":30,"phoneExt":30,"email":30},"Wenzhe Fan","SUB_INVESTIGATOR",{"facility":97,"status":30,"city":74,"state":75,"zip":98,"country":77,"countryCode":78,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Jinshazhou Hospital of Guangzhou University of Chinese Medicine","510168",{"type":80,"coordinates":100},[82,83],{"lat":83,"lon":82},[103],{"name":104,"role":64,"phone":105,"phoneExt":30,"email":106},"Liangliang Qiao","+86 13544539881","271937316@qq.com",{"facility":108,"status":30,"city":74,"state":75,"zip":109,"country":77,"countryCode":78,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Guangdong Second People's Hospital","510317",{"type":80,"coordinates":111},[82,83],{"lat":83,"lon":82},[114],{"name":115,"role":64,"phone":116,"phoneExt":30,"email":117},"Chengjiang Xiao","+86 13602808387","Xxx196610@163.com",{"facility":119,"status":30,"city":74,"state":75,"zip":120,"country":77,"countryCode":78,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"The Affiliated Panyu Central Hospital of Guangzhou Medical University","511400",{"type":80,"coordinates":122},[82,83],{"lat":83,"lon":82},[125],{"name":126,"role":64,"phone":127,"phoneExt":30,"email":128},"Fuxi Huang","+86 18902299938","Fuxihuang2006@126.com",{"facility":130,"status":30,"city":74,"state":75,"zip":131,"country":77,"countryCode":78,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},"The Second Affiliated Hospital of Guangdong Medical University","524003",{"type":80,"coordinates":133},[82,83],{"lat":83,"lon":82},[136],{"name":137,"role":64,"phone":138,"phoneExt":30,"email":139},"Kangshun Zhu","+86 13602864242","Zhksh010@163.com",{"facility":141,"status":30,"city":142,"state":75,"zip":143,"country":77,"countryCode":78,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Jiangmen Central Hospital","Jiangmen","529030",{"type":80,"coordinates":145},[146,147],113.08333,22.58333,{"lat":147,"lon":146},[150],{"name":151,"role":64,"phone":152,"phoneExt":30,"email":153},"Yuchuang Liang","+86 13322888181","jmlyc@21cn.com",{"facility":155,"status":30,"city":156,"state":157,"zip":158,"country":77,"countryCode":78,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Wuhan Union Hospital of China","Wuhan","Hubei","430022",{"type":80,"coordinates":160},[161,162],114.26667,30.58333,{"lat":162,"lon":161},[165],{"name":166,"role":64,"phone":167,"phoneExt":30,"email":168},"Xuefeng Kan","+86 13545874189","xkliulang1314@163.com",{"facility":170,"status":30,"city":171,"state":172,"zip":173,"country":77,"countryCode":78,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"The Second Xiangya Hospital of Central South University","Changsha","Hunan","410011",{"type":80,"coordinates":175},[176,177],112.97087,28.19874,{"lat":177,"lon":176},[180],{"name":181,"role":64,"phone":182,"phoneExt":30,"email":183},"Yudong Xiao","+86 136 3740 3027","xiaoyudong222@csu.edu.cn",{"facility":185,"status":30,"city":171,"state":172,"zip":186,"country":77,"countryCode":78,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},"The Third Xiangya Hospital of Central South University","410013",{"type":80,"coordinates":188},[176,177],{"lat":177,"lon":176},[191],{"name":192,"role":64,"phone":193,"phoneExt":30,"email":194},"Qi Liang","+86 137 8731 8180","csuliangqi10@163.com",{"facility":196,"status":30,"city":197,"state":198,"zip":199,"country":77,"countryCode":78,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Ganzhou Hospital-Nanfang Hospital, Southern Medical University","Ganzhou","Jiangxi","341000",{"type":80,"coordinates":201},[202,203],114.9326,25.84664,{"lat":203,"lon":202},[206],{"name":207,"role":64,"phone":208,"phoneExt":30,"email":209},"Yusheng Song","+86 135 7675 2988","646993126@qq.com",{"facility":211,"status":30,"city":212,"state":198,"zip":213,"country":77,"countryCode":78,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"The First Affiliated Hospital of Nanchang University","Nanchang","330209",{"type":80,"coordinates":215},[216,217],115.85306,28.68396,{"lat":217,"lon":216},[220],{"name":221,"role":64,"phone":222,"phoneExt":30,"email":223},"Junhua Ai","+86 18170936163","aijh0001@163.com",{"facility":225,"status":30,"city":226,"state":227,"zip":228,"country":77,"countryCode":78,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"The Affiliated Hospital of QingDao University","Qingdao","Shandong","266000",{"type":80,"coordinates":230},[231,232],120.38042,36.06488,{"lat":232,"lon":231},[235],{"name":236,"role":64,"phone":237,"phoneExt":30,"email":238},"Song Wang","+86 18661805592","derekqyfy@126.com",{"facility":240,"status":30,"city":241,"state":242,"zip":243,"country":77,"countryCode":78,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"West China School of Medicine\u002FWest China Hospital, Sichuan University (WCSM\u002FWCH, SCU)","Chengdu","Sichuan","610041",{"type":80,"coordinates":245},[246,247],104.06667,30.66667,{"lat":247,"lon":246},[250],{"name":251,"role":64,"phone":252,"phoneExt":30,"email":253},"Chang Liu","+86 18980606382","drliuchang@wchscu.cn",{"facility":5,"status":30,"city":255,"state":256,"zip":257,"country":77,"countryCode":78,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Hangzhou","Zhejiang","310022",{"type":80,"coordinates":259},[260,261],120.16142,30.29365,{"lat":261,"lon":260},[264,267,269],{"name":265,"role":64,"phone":266,"phoneExt":30,"email":66},"Gaojun Teng","+86 0571 - 88122222",{"name":268,"role":64,"phone":69,"phoneExt":30,"email":70},"Binyan Zhong",{"name":270,"role":95,"phone":30,"phoneExt":30,"email":30},"Jiaping Zheng",{"facility":272,"status":30,"city":273,"state":256,"zip":274,"country":77,"countryCode":78,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Jinhua Municipal Central Hospital","Jinhua","321000",{"type":80,"coordinates":276},[277,278],119.64421,29.10678,{"lat":278,"lon":277},[281],{"name":282,"role":64,"phone":283,"phoneExt":30,"email":284},"Xiaogang Hu","+86 135 8866 8173","heartdoctor@163.com",{"facility":286,"status":30,"city":287,"state":256,"zip":288,"country":77,"countryCode":78,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"Lishui Central Hospital","Lishui","323020",{"type":80,"coordinates":290},[291,292],119.91029,28.46042,{"lat":292,"lon":291},[295,299],{"name":296,"role":64,"phone":297,"phoneExt":30,"email":298},"Jiansong Ji","+86 0578-2285888","jjstcty@sina.com",{"name":300,"role":64,"phone":30,"phoneExt":30,"email":301},"Jianfei Tu","jianfei1133@163.com",{"facility":303,"status":30,"city":304,"state":256,"zip":305,"country":77,"countryCode":78,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"NingBo No.2 Hospital","Ningbo","315010",{"type":80,"coordinates":307},[308,309],121.54945,29.87819,{"lat":309,"lon":308},[312],{"name":313,"role":64,"phone":314,"phoneExt":30,"email":315},"Yunjie Chen","+86 13857877137","a88960317@163.com",{"facility":317,"status":30,"city":304,"state":256,"zip":318,"country":77,"countryCode":78,"cosmosGeoPoint":319,"geoPoint":321,"contacts":322},"NingBo Medical Center Lihuili Hospital","315048",{"type":80,"coordinates":320},[308,309],{"lat":309,"lon":308},[323],{"name":324,"role":64,"phone":325,"phoneExt":30,"email":326},"Shengdong Wu","+86 13567886669","13567886669@139.com",{"type":55,"investigatorFullName":328,"investigatorTitle":329,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Gao-Jun Teng","Director, Interventional Oncology Center","100645572","phase-3-intraarterial-therapies-plus-tislelizumab-plus-lenvatinib-versus-tislelizumab-plus-gemcitabine-cisplatin-in-unresectable-intrahepatic-cholangiocarcinoma-100645572",false,"NCT07691515","Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma","Transcatheter Arterial Chemoembolization in Combination With Tislelizumab Plus Lenvatinib Versus Systemic Cisplatin Plus Gemcitabine in Combination With Tislelizumab for Unresectable Intrahepatic Cholangiocarcinoma: A Phase III, Multicenter, Randomized Controlled Trial","RAINBOW","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed intrahepatic cholangiocarcinoma that is unresectable or recurrent after curative treatment, without extrahepatic metastasis.\n3. No prior systemic therapy or transarterial interventional therapy for intrahepatic cholangiocarcinoma.\n4. At least one measurable intrahepatic lesion according to RECIST v1.1.\n5. ECOG performance status of 0 or 1.\n6. Child-Pugh class A liver function.\n7. Life expectancy ≥3 months.\n8. Adequate hematologic, hepatic, renal, and thyroid function within 14 days before study start, defined as:\n\n   * Absolute neutrophil count ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥75 × 10⁹\u002FL;\n   * Hemoglobin ≥90 g\u002FL;\n   * Serum albumin ≥30 g\u002FL;\n   * Total bilirubin ≤1.5 × upper limit of normal;\n   * AST and ALT \\\u003C1.5 × upper limit of normal, and ALP \\\u003C4 × upper limit of normal;\n   * TSH \\\u003C1 × upper limit of normal, with T3 and T4 within the normal range;\n   * Serum creatinine \\\u003C1.5 × upper limit of normal and creatinine clearance ≥60 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Diffuse infiltrative liver lesions.\n2. Contraindications to TACE.\n3. Allergy to intravenous contrast agent.\n4. pregnant or breastfeeding women, or participants planning pregnancy within 2 years \u002F unwilling to use effective contraception.\n5. Patients with HIV or syphilis infection.\n6. Patients with concurrent malignancies or other malignancies within 5 years before enrollment.\n7. History of allogeneic organ transplantation.\n8. Severe dysfunction of the heart, kidney, or other organs.\n9. Severe clinically active infection \\> grade 2 according to NCI-CTC v5.0.\n10. Psychiatric illness that may affect the informed consent process; Inability to take oral medications; Participation in another drug clinical trial within 12 months before enrollment.","ALL","18 Years",{"count":341,"type":342},140,"ESTIMATED","INTERVENTIONAL",[345],"PHASE3","This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma.\n\nApproximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol.\n\nThe primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.",[348],"Intrahepatic Cholangiocarcinoma (Icc)",[350,351,45,36,40,352],"Intrahepatic Cholangiocarcinoma","randomized controlled trial","GemCis","NOT_YET_RECRUITING","2026-07-13",{"date":356,"type":357},"2026-07-14","ACTUAL",{"date":359,"type":342},"2026-07",{"date":361,"type":342},"2030-07",{"name":5,"class":6},18]