Perioperative PD-1 antibody tislelizumab plus chemotherapy for locally advanced gastro-oesophageal junction cancer: A prospective, nonrandomized, open-label, phase II trial.

作者：Run‐Cong Nie, Ya Ding, Shuqiang Yuan, Yuanfang Li, Wei Wang, Yongming Chen, Muyan Cai, Xiao Sun, Desheng Weng, Dandan Li, Jingjing Zhao, Xiao Jiang Chen, Yuanxiang Guan, Ma Luo, Haibo Qiu, Zhiwei Zhou, Xiaoshi Zhang, Yingbo Chen · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.4083 · 被引用次数：1 · 研究领域：Gastric Cancer Management and Outcomes、Gastrointestinal Tumor Research and Treatment、Cancer Immunotherapy and Biomarkers

4083 Background: The combination of PD-1 antibody and chemotherapy was shown to be effective in advanced gastric cancer, but has not yet been comprehensively investigated in locally advanced patients, especially in the context of adenocarcinoma of gastro-oesophageal junction (GEJ). In this study, we conducted a prospective, nonrandomized, open-label phase II trial to evaluate the effectiveness of adding PD-1 antibody to perioperative chemotherapy in patients with locally advanced resectable GEJ cancer. Methods: In this nonrandomized, open-label, phase II study, patients with resectable GEJ adenocarcinoma clinically staged as cT3-4aNanyM0 or cT1-2N+M0 were allocated three preoperative and five postoperative 3-week cycles of PD-1 antibody tislelizumab plus SOX (S-1 and oxaliplatin) regimen. The primary endpoint was major pathological response (MPR) rate. The secondary endpoints were pathological complete response (pCR), pathological complete /moderate regression rate (TRG 0/1), R0 resection rate, recurrence-free survival, event-free survival, overall survival, treatment safety and quality of life. The trial is registered at Chinese Clinical Trial Registry, identifier: ChiCTR2200058732. Results: Between Oct 2022 and June 2023, 32 patients were enrolled and assessed using intention-to-treat analysis. The median age was 60 years (range: 28-74 years), and 53.1% (17/32) patients were Siewert III type. All patients received at least one cycle of assigned preoperative treatment, and 9...