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Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study
Sponsor: Peking Union Medical College Hospital
Summary
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.
Official title: A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
90
Start Date
2025-05-04
Completion Date
2029-12-31
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Adebrelimab
Adebrelimab administered intravenously at \[1200mg\] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
Gemcitabine
Gemcitabine administered intravenously at \[1000 mg/m\^2\] on days 1 and 8 of each \[21\]-day cycle, for up to 8 cycles, in combination with cisplatin and adebrelimab,
Cisplatin
Cisplatin administered intravenously at \[25 mg/m\^2\] on days 1 and 8 of each \[21\]-day cycle, for up to 8 cycles, in combination with gemcitabine and adebrelimab.
S-1
S-1 (tegafur/gimeracil/oteracil) 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.
Apatinib
Apatinib administered orally at \[250mg\] once daily continuously, for up to 17 cycles, in combination with adebrelimab.
Locations (1)
Peking Union Medical College Hospital (PUMCH)
Beijing, China