A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors
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.
• 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.