Real-World Evaluation of Adjuvant Treatments Combined with Adebrelimab in Patients with High-Risk Postoperative Intrahepatic Cholangiocarcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of different adjuvant therapies in patients with intrahepatic cholangiocarcinoma ICC who have undergone surgery and have high-risk factors for cancer returning. This real-world multicenter study compares three treatment combinations against historical controls to understand which may better prevent recurrence in this patient group. Participants are assigned to one of three treatment groups Cohort 1 receives gemcitabine and cisplatin plus adebrelimab Cohort 2 receives apatinib plus adebrelimab Cohort 3 receives S-1 plus adebrelimab. Adebrelimab is given intravenously every 21 days for up to 17 cycles across all groups. Gemcitabine and cisplatin are given intravenously on days 1 and 8 every 21 days for up to 8 cycles in Cohort 1. Apatinib is taken orally daily for up to 17 cycles in Cohort 2. S-1 is taken orally twice daily for 14 days in each 21-day cycle for up to 8 cycles in Cohort 3. During the study, participants will be monitored for recurrence-free survival over an average of 4 years, along with overall survival. Researchers will assess safety and treatment responses through regular check-ups and evaluations. Participants agree to use effective contraception and maintain compliance with study procedures throughout the trial, which lasts until study completion in 2029.

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