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RECRUITING
NCT07640048

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

Interventions

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.

DRUG

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,

DRUG

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.

DRUG

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.

DRUG

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