Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer

作者：Jianming Xu, Haiping Jiang, Yueyin Pan, Kangsheng Gu, Shundong Cang, Lei Han, Yongqian Shu, Jiayi Li, Junhui Zhao, Hongming Pan, Suxia Luo, Yanru Qin, Qunyi Guo, Yuxian Bai, Ling Yang, Jianwei Yang, Zhilong Yan, Lei Yang, Yong Tang, Yifu He, Liangming Zhang, Xinjun Liang, Zuoxing Niu, Jingdong Zhang, Yong Mao, Yingmei Guo, Bo Peng, Ziran Li, Ying Liu, Yan Wang, Hui Zhou, ORIENT-16 Investigators, Hongmei Sun, Qi Wang, Junhe Li, Da Jiang, Weijian Guo, Jieer Ying, Shubin Wang, Aimin Zang, Shirong Cai, Chunhong Hu, Tao Zhang, Min Tao, Jun Liang, Qinsheng Mao, Minghui Zhang, Rui Mao, Hui Yang, Hongyu Zhang, Lin Shen, Jin Lu, Wenxin Li, Yamin Chen, Lei Chen, Zhixiang Zhuang, Chunmei Bai, Heli Liu, Jingtang Chen, Wangjun Liao, Meng Qiu, Rongfeng Song, Man Li, S. B. Qian, Yunpeng Liu, Jiang Liu, Dong Wang, Xianli Yin, Zhiming Huang · 发表于：JAMA · 年份：2023 · DOI：10.1001/jama.2023.19918 · 被引用次数：383 · 研究领域：Esophageal Cancer Research and Treatment、Cancer Immunotherapy and Biomarkers、Gastric Cancer Management and Outcomes

Importance: Gastric and gastroesophageal junction cancers are diagnosed in more than 1 million people worldwide annually, and few effective treatments are available. Sintilimab, a recombinant human IgG4 monoclonal antibody that binds to programmed cell death 1 (PD-1), in combination with chemotherapy, has demonstrated promising efficacy. Objective: To compare overall survival of patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancers who were treated with sintilimab with chemotherapy vs placebo with chemotherapy. Also compared were a subset of patients with a PD ligand 1 (PD-L1) combined positive score (CPS) of 5 or more (range, 1-100). Design, Setting, and Participants: Randomized, double-blind, placebo-controlled, phase 3 clinical trial conducted at 62 hospitals in China that enrolled 650 patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma between January 3, 2019, and August 5, 2020. Final follow-up occurred on June 20, 2021. Interventions: Patients were randomized 1:1 to either sintilimab (n = 327) or placebo (n = 323) combined with capecitabine and oxaliplatin (the XELOX regimen) every 3 weeks for a maximum of 6 cycles. Maintenance therapy with sintilimab or placebo plus capecitabine continued for up to 2 years. Main Outcomes and Measures: The primary end point was overall survival time from randomization. Results: Of the 650 patients (mean age, 59 years; 483 [74.3%] m...