[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643566":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":45,"centralContacts":52,"locations":58,"responsibleParty":72,"collaborators":10,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":10,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,15,19],{"label":9,"type":10,"description":10,"interventionNames":11},"Cohort 1: GP + adebrelimab",null,[12,13,14],"Drug: Adebrelimab","Drug: Gemcitabine","Drug: Cisplatin",{"label":16,"type":10,"description":10,"interventionNames":17},"Cohort 2: Apatinib + adebrelimab",[12,18],"Drug: Apatinib",{"label":20,"type":10,"description":10,"interventionNames":21},"Cohort 3: S-1 + adebrelimab",[12,22],"Drug: S-1",[24,29,33,37,41],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"DRUG","Adebrelimab","Adebrelimab administered intravenously at \\[1200mg\\] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.",[9,16,20],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"Gemcitabine","Gemcitabine administered intravenously at \\[1000 mg\u002Fm\\^2\\] on days 1 and 8 of each \\[21\\]-day cycle, for up to 8 cycles, in combination with cisplatin and adebrelimab，",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Cisplatin","Cisplatin administered intravenously at \\[25 mg\u002Fm\\^2\\] on days 1 and 8 of each \\[21\\]-day cycle, for up to 8 cycles, in combination with gemcitabine and adebrelimab.",[9],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"S-1","S-1 (tegafur\u002Fgimeracil\u002Foteracil) administered orally twice daily on days 1-14 of each 21-day cycle, dosed according to body surface area, for up to 8 cycles, in combination with adebrelimab.",[20],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"Apatinib","Apatinib administered orally at \\[250mg\\] once daily continuously, for up to 17 cycles, in combination with adebrelimab.",[16],[46,50],{"name":47,"affiliation":48,"role":49},"Shunda Du","Peking Union Medical College Hospital (PUMCH)","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":48,"role":49},"Mei Guan",[53],{"name":54,"role":55,"phone":56,"phoneExt":10,"email":57},"Baoluhe Zhang","CONTACT","010-69152831","dushd@pumch.cn",[59],{"facility":48,"status":60,"city":61,"state":10,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Beijing","China","CN",{"type":65,"coordinates":66},"Point",[67,68],116.39723,39.9075,{"lat":68,"lon":67},[71],{"name":54,"role":55,"phone":56,"phoneExt":10,"email":57},{"type":49,"investigatorFullName":47,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Chief Physician, Professor","100643566","adjuvant-therapy-for-high-risk-intrahepatic-cholangiocarcinoma-a-real-world-study-100643566",false,"NCT07640048","Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study","A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors","Inclusion Criteria:\n\n* Histologically confirmed ICC within 12 weeks after curative resection\n* Any T stage; N0\u002FN+; M0.\n* At least one high-risk factor:\n\nPreoperative tumor penetration of the liver capsule or extrahepatic direct invasion; Preoperative imaging showing multifocal lesions or a single lesion \\>5 cm; Vascular invasion (preoperative or postoperative pathology); Regional lymph node metastasis.\n\n* No prior systemic therapy for ICC.\n* ECOG performance status 0-2.\n* Expected survival ≥3 months.\n* Adequate organ function.\n* Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose.\n* Signed informed consent and anticipated good compliance with the study protocol.\n\nExclusion Criteria:\n\n* Immunosuppressive therapy within 28 days prior to enrollment (excluding topical\u002Finhaled corticosteroids or physiologic steroid doses ≤10 mg\u002Fday prednisone equivalent).\n* Systemic anticancer herbs\u002Fimmunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control.\n* Uncontrolled cardiovascular disease:\n\nUnstable angina\u002Fmyocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF \\\u003C50%\n\n* Active infections (IV antibiotics\u002Fantivirals required) or fever \\>38.5°C within 4 weeks; or major surgery within 3 weeks.\n* Active autoimmune\u002Fimmunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except:\n\nHypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed).\n\n\\- Active infections: HIV\u002FAIDS\n\nHBV (DNA ≥500 IU\u002FmL) or HCV (RNA-positive) unless:\n\nHBV DNA \\\u003C500 IU\u002FmL + antiviral therapy ≥14 days\n\n* Prior\u002Fproposed organ transplantation (excluding corneal grafts).\n* Concurrent interventional trials or investigational drugs within 4 weeks without recovery to Grade ≤1 toxicity.\n* Hypersensitivity to study drug components.\n* Allogeneic transplant history\u002Fplans.\n* Uncontrolled psychiatric\u002Fsubstance abuse disorders.\n* Refractory hypertension (≥140\u002F90 mmHg despite treatment).\n* Clinically significant bleeding\u002Fthromboembolism:\n\nGI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT\u002FPE)\n\n* Coagulopathy (INR \\>1.5, PT \\>ULN+4s, aPTT \\>1.5×ULN) or anticoagulant use.\n* Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g.\n* Other high-risk conditions per investigator judgment.","ALL","18 Years",{"count":84,"type":85},90,"ESTIMATED","OBSERVATIONAL","This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors.\n\n90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine\u002Fcisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur\u002Fgimeracil\u002Foteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.",[89],"Intrahepatic Cholangiocarcinoma (Icc)","2026-06-05",{"date":92,"type":93},"2026-06-10","ACTUAL",{"date":95,"type":93},"2025-05-04",{"date":97,"type":85},"2029-12-31",{"name":5,"class":6},1]