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Treatment options for patients with HER2-positive advanced gastric cancer are limited, and the prognosis for these patients is poor. Pembrolizumab has demonstrated promising antitumor activity in patients with advanced gastric or gastroesophageal junction adenocarcinoma as monotherapy, in combination with chemotherapy and in combination with trastuzumab. Combining pembrolizumab with trastuzumab and chemotherapy may therefore provide a benefit for patients with advanced HER2-positive gastric cancer. Here we aimed to describe the design of and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-811 study, which will evaluate the efficacy and safety of pembrolizumab or placebo in combination with trastuzumab and chemotherapy as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. Clinical trial registration: NCT03615326 (ClinicalTrials.gov). HER2阳性晚期胃癌患者的治疗选择有限，这些患者的预后较差。Pembrolizumab 作为单一疗法、联合化疗和联合曲妥珠单抗，已在晚期胃或胃食管结合部腺癌患者中显示出有希望的抗肿瘤活性。因此，将派姆单抗与曲妥珠单抗和化学疗法相结合可能会为晚期HER2阳性胃癌患者带来益处。在这里，我们旨在描述随机、双盲、安慰剂对照的III期 KEYNOTE-811 研究的设计和基本原理，这将评估派姆单抗或安慰剂联合曲妥珠单抗和化疗作为晚期HER2阳性胃癌或胃食管结合部腺癌患者的一线治疗的疗效和安全性。临床试验注册：NCT03615326 (ClinicalTrials.gov)。 
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