Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer

作者：Xiao Han, Jiansong Ji, Shaoqiang Li, Jiaming Lai, Guangyan Wei, Jian Wu, Wei Chen, Wenxuan Xie, Shutong Wang, Liangliang Qiao, Jianfei Tu, Shunli Shen, Zhenwei Peng · 发表于：JAMA Oncology · 年份：2025 · DOI：10.1001/jamaoncol.2025.1926 · 被引用次数：15 · 研究领域：Cholangiocarcinoma and Gallbladder Cancer Studies、Gallbladder and Bile Duct Disorders、Liver Diseases and Immunity

Importance: Extrahepatic cholangiocarcinoma (EHC) and gallbladder cancer (GBC), which make up most biliary tract cancers, have distinct molecular and clinical features compared with intrahepatic cholangiocarcinoma. However, effective adjuvant treatments specifically for patients with resectable EHC and GBC are scarce. Objective: To evaluate the safety and efficacy of immunotherapy combining with chemoradiotherapy. Design, Setting, and Participants: In the ACCORD randomized clinical trial, from April 2020 to June 2022, patients with EHC and GBC after curative resection were assessed for eligibility. Patients were randomized 1:1 into to the combination camrelizumab plus concurrent capecitabine and radiotherapy group or the observation group. Data were analyzed from June to August 2024. Interventions: The intervention group received camrelizumab every 3 weeks after surgery. After 2 courses of camrelizumab treatment, patients received capecitabine with concurrent radiotherapy. Patients in the observation group received no anticancer treatment unless relapse was detected. Main Outcomes and Measures: The primary end point was overall survival (OS) and the secondary end points included recurrence-free survival (RFS) and safety. Results: Of 93 included patients, 48 (52%) were female, and the median (range) age was 62 (31-70) years. Patients' baseline characteristics were comparable in the 2 groups. With a median (IQR) follow up of 36 (32-39) months, patients in the combination treatm...