Camrelizumab plus CAPOX with camrelizumab based maintenance versus CAPOX alone as initial treatment for gastric or gastro-oesophageal junction adenocarcinoma: randomised phase 3 trial

作者：Z S Peng, Yanqiao Zhang, H. Xu, Yan Yang, Mudan Yang, M. Zhang, Ying Cheng, Xiaobing Chen, Yueyin Pan, Feng Wang, Qingshan Li, N. Xu, Likun Liu, K. Gu, Juxiang Xiao, Ruixing Zhang, Q. Zhao, Jian Chen, Lizhu Lin, Yigui Chen, Yayin Deng, Shirong Cai, Bin Bai, Yiru Wang, Lin Shen · 发表于：BMJ · 年份：2026 · DOI：10.1136/bmj-2025-086115 · 被引用次数：4 · 研究领域：Gastric Cancer Management and Outcomes、Esophageal Cancer Research and Treatment、Intraperitoneal and Appendiceal Malignancies

Abstract Objective To compare camrelizumab plus capecitabine and oxaliplatin followed by camrelizumab plus apatinib (camre+CAPOX followed by camre+apa), CAPOX alone, and camrelizumab plus CAPOX followed by camrelizumab (camre+CAPOX followed by camre) as initial treatment for gastric or gastro-oesophageal junction adenocarcinoma. Design Randomised, open label, phase 3 study. Setting 75 hospitals in China, 13 March 2019 to 16 August 2021. Participants 885 adults (≥18 years) with previously untreated, human epidermal growth factor receptor 2 (HER2) negative, unresectable, locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Interventions Patients were randomised (2:2:1) to receive camre+CAPOX followed by camre+apa, CAPOX only, or camre+CAPOX followed by camre, stratified by Eastern Cooperative Oncology Group performance status, peritoneal metastasis, and programmed death ligand 1 (PD-L1) combined positive score. Assignment to camre+CAPOX followed by camre was introduced midway through enrolment. Main outcome measures The primary endpoint was overall survival for camre+CAPOX followed by camre+apa versus CAPOX alone in the PD-L1 positive population (combined positive score >1) and the overall population who received at least one dose of study drug. Comparisons of camre+CAPOX followed by camre versus CAPOX alone and of camre+CAPOX followed by camre+apa versus camre+CAPOX–camre were descriptive. Safety was assessed in all patients who received at ...