Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer

• DOI: 10.1001/jama.2023.19918
• Publication Date: 2023-12-05T16:29:50Z
• Authors: 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; Yang Ling; 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; ; 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; Suying Qian; Yunpeng Liu; Jiang Liu; Dong Wang; Xianli Yin; Zhiming Huang
• Keywords: Regimen; Chemotherapy regimen; Clinical endpoint

Importance Gastric and gastroesophageal junction cancers are diagnosed in more than 1 million people worldwide annually, few effective treatments available. Sintilimab, a recombinant human IgG4 monoclonal antibody that binds to programmed cell death (PD-1), combination with chemotherapy, has demonstrated promising efficacy. Objective To compare overall survival of patients unresectable locally advanced or metastatic gastric who were treated sintilimab chemotherapy vs placebo chemotherapy. Also compared subset PD ligand (PD-L1) combined positive score (CPS) 5 (range, 1-100). Design, Setting, Participants Randomized, double-blind, placebo-controlled, phase 3 clinical trial conducted at 62 hospitals China enrolled 650 adenocarcinoma between January 3, 2019, August 5, 2020. Final follow-up occurred on June 20, 2021. Interventions Patients randomized 1:1 either (n = 327) 323) capecitabine oxaliplatin (the XELOX regimen) every weeks for maximum 6 cycles. Maintenance therapy plus continued up 2 years. Main Outcomes Measures The primary end point was time from randomization. Results Of the (mean age, 59 years; 483 [74.3%] men), 327 323 Among patients, 397 (61.1%) had tumors PD-L1 CPS more; 563 (86.6%) discontinued study treatment 388 (59.7%) died; patient (<0.1%) lost follow-up. all improved (median, 15.2 12.3 months; stratified hazard ratio [HR], 0.77 [95% CI, 0.63-0.94]; P .009). more, 18.4 12.9 HR, 0.66 0.50-0.86]; .002). most common grade higher treatment-related adverse events decreased platelet count (sintilimab, 24.7% placebo, 21.3%), neutrophil 20.1% 18.8%), anemia 12.5% 8.8%). Conclusions Relevance first-line significantly placebo. Trial Registration ClinicalTrials.gov Identifier: NCT03745170