Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

Phase 2 Unknown 92 enrolled Sun Yat-sen University

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

Timeline

Start: 2020-06-01
Primary completion: 2024-06
Completion: 2024-06

Outcome

Met primary endpoint

paper significantly better OS and RFS PMID 40638104 ↗

paper hazard ratio, 0.43; 95% CI, 0.24-0.79; P = .004 PMID 40638104 ↗

Publications

Xiao H, Ji J, Li S, Lai J, Wei G, Wu J, Chen W, Xie W, Wang S, Qiao L, Tu J, Shen S, Peng Z. Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1021-1029. doi: 10.1001/jamaoncol.2025.1926.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1330 mg/m2	—