biostudies-literatureUnknown330(21)Xu J<h4>Importance</h4>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.<h4>Objective</h4>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).<h4>Design, setting, and participants</h4>Randomized, double-blind, placebo-controlled, phase 3 JAMA2064-2074https://www.ebi.ac.uk/biostudies/studies/S-EPMC10698618biostudies-literatureSintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial.PMC10698618Shen LLiang XZhang JGuo YGuo WZhang HWang DYing JZhang MZhang LQiu MGuo QYan ZWang QWang SLiang JChen YGu KShu YORIENT-16 InvestigatorsWang YSun HYang HYang JLi JYang LChen JChen LLiao WXu JLi MLi WHu CLi ZHe YLu JJiang DLiu HBai CLiu JCai SHan LMao QJiang HMao RNiu ZQin YLiu YSong RZhao JZhou HTang YMao YYin XTao MPan YLing YBai YZhuang ZPan HZhang TCang SQian SHuang ZPeng BLuo SZang AfalseSintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial.<h4>Importance</h4>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.<h4>Objective</h4>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).<h4>Design, setting, and participants</h4>Randomized, double-blind, placebo-controlled, phase 3 2023-01-01T00:00:00Z2023 Dec2026-06-03T06:44:58.288Z2026-04-25T03:22:25.351ZS-EPMC106986183805132810.1001/jama.2023.19918