Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study

This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors. 90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.

Inclusion Criteria: * Histologically confirmed ICC within 12 weeks after curative resection * Any T stage; N0/N+; M0. * At least one high-risk factor: Preoperative 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. * No prior systemic therapy for ICC. * ECOG performance status 0-2. * Expected survival ≥3 months. * Adequate organ function. * Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose. * Signed informed consent and anticipated good compliance with the study protocol. Exclusion Criteria: * Immunosuppressive therapy within 28 days prior to enrollment (excluding topical/inhaled corticosteroids or physiologic steroid doses ≤10 mg/day prednisone equivalent). * Systemic anticancer herbs/immunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control. * Uncontrolled cardiovascular disease: Unstable angina/myocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF \38.5°C within 4 weeks; or major surgery within 3 weeks. * Active autoimmune/immunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except: Hypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed). \- Active infections: HIV/AIDS HBV (DNA ≥500 IU/mL) or HCV (RNA-positive) unless: HBV DNA \1.5, PT \>ULN+4s, aPTT \>1.5×ULN) or anticoagulant use. * Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g. * Other high-risk conditions per investigator judgment.