[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620952":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":21,"locations":27,"responsibleParty":54,"collaborators":21,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":21,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":30,"whyStopped":21,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Eastern Hepatobiliary Surgery Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HAIC combined with PD-L1 inhibitor","EXPERIMENTAL","Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic\n\narterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was\n\nadopted, with the specific regimen as follows: Cisplatin 20mg\u002Fm2, maintained for 3 hours. Gemcitabine 0.6g\u002Fm2,\n\nmaintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles\n\nwas determined by the investigator according to the patient's condition). 2. PD-L1 inhibitor Drug: Durvalumab\n\nOR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5\n\nof each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab:\n\nDuring combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle\n\n(determined by the investigator); during maintenance therapy: 200 mg Q4W",[13,14],"Drug: PD-L1 inhibitor","Procedure: HAIC",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","PD-L1 inhibitor","PD-L1 inhibitor Drug: Durvalumab OR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab: During combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 200 mg Q4W",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","HAIC","Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic arterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: Cisplatin 20mg\u002Fm2, maintained for 3 hours. Gemcitabine 0.6g\u002Fm2, maintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles was determined by the investigator according to the patient's condition).",[9],[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Shanghai Eastern Hepatobiliary Surgery Hospital","RECRUITING","Shanghai","Shanghai Municipality","200438","China","CN",{"type":37,"coordinates":38},"Point",[39,40],121.45806,31.22222,{"lat":40,"lon":39},[43,48,51],{"name":44,"role":45,"phone":46,"phoneExt":21,"email":47},"zhitao Dong, Dr","CONTACT","+86-021-81887834","dongzt2012@sina.com",{"name":49,"role":45,"phone":46,"phoneExt":21,"email":50},"kunpeng fang, Dr","wuguozhong@126.com",{"name":52,"role":53,"phone":21,"phoneExt":21,"email":21},"chengjun sui, Dr","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Chengjun Sui,MD","Professor","100620952","phase-2-haic-combined-with-immune-therapy-for-advanced-non-resectable-icc-100620952",false,"NCT07364305","HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC","HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial","Lalo","Inclusion Criteria:\n\n1. Age: Age ≥ 18 years old.\n2. Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.\n3. Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).\n4. Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.\n5. Expected lifespan: Expected lifespan ≥ 3 months.\n6. Liver function: Child Pugh classification A or B.\n7. Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.\n8. Not receiving relevant treatment: Not receiving systematic treatment for ICC.\n\nExclusion Criteria:\n\n1. Previous treatment: Previously received systemic treatment for ICC.\n2. Poor physical condition: ECOG physical condition score ≥ 2.\n3. Poor liver function: Child Pugh grading\\>8.\n4. Short life expectancy: Life expectancy is less than 3 months.\n5. Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors.\n6. Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.\n7. Drug allergy or intolerance: Allergic to the investigational drug or its excipients.\n8. Other: Other situations that the researcher deems unsuitable to participate in this study",true,"ALL","18 Years","75 Years",{"count":70,"type":71},50,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.",[77,78],"ICC","Advanced Cancer",[24,80],"Immunotherapy","2026-01-15",{"date":83,"type":84},"2026-01-23","ACTUAL",{"date":86,"type":84},"2025-01-01",{"date":88,"type":71},"2028-01-01",{"name":5,"class":6},1]