Nie Run-Cong, Yuan Shu-Qiang, Ding Ya, Chen Yong-Ming, Li Yuan-Fang, Liang Cheng-Cai, Cai Mu-Yan, Chen Guo-Ming, Wang Wei, Sun Xiao-Wei, Weng De-Sheng, Li Dan-Dan, Zhao Jing-Jing, Chen Xiao-Jiang, Guan Yuan-Xiang, Liu Zhi-Min, Liang Yao, Luo Ma, Chi Jun, Qiu Hai-Bo, Zhou Zhi-Wei, Zhang Xiao-Shi, Chen Ying-Bo
Department of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, PR China.
Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, PR China.
Signal Transduct Target Ther. 2025 Feb 5;10(1):60. doi: 10.1038/s41392-025-02160-8.
This prospective, nonrandomized, open-label phase 2 trial (Chinese Clinical Trial Registry, ChiCTR2200061906) aimed to evaluate the effectiveness of adding the PD-1 antibody tislelizumab to perioperative chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma (GEJA). This study enrolled patients with GEJA clinically staged as cT3-4aNanyM0 or cT1-2N+M0 from October 2022 to June 2023. Eligible patients were administered three preoperative and five postoperative 3-week cycles of treatment with PD-1 antibody tislelizumab plus SOX (S-1 and oxaliplatin) regimen. The primary endpoint was major pathological response (MPR) rate. Thirty-two patients were enrolled. 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 93.8% (30/32) patients completed three cycles of assigned preoperative tislelizumab and SOX. The R0 resection rate was 96.9% (31/32). MPR, pathological complete response (pCR) of primary tumors and ypT0N0 rates were 50.0% (16/32, 95% CI: 31.9-68.1%), 28.1% (9/32, 95% CI: 13.7-46.7%) and 25.0% (8/32, 95% CI: 11.5-43.4%), respectively. The surgical morbidity rate was 15.6% (5/32), and no 30-day mortality was observed. In the preoperative and postoperative treatment periods, the rate of treatment-related grade 3-4 adverse events was 31.2% (10/32). At the date of 7 Jan 2025, 8 (25.0%) patients occurred recurrence. Therefore, perioperative tislelizumab plus chemotherapy demonstrated significantly improved pathological regression and might be a promising option for patients with locally advanced resectable GEJA.
这项前瞻性、非随机、开放标签的2期试验（中国临床试验注册中心，ChiCTR2200061906）旨在评估在局部晚期胃食管交界腺癌（GEJA）患者的围手术期化疗中添加PD-1抗体替雷利珠单抗的有效性。本研究纳入了2022年10月至2023年6月期间临床分期为cT3-4aNanyM0或cT1-2N+M0的GEJA患者。符合条件的患者接受了三个术前周期和五个术后周期、为期3周的PD-1抗体替雷利珠单抗联合SOX（S-1和奥沙利铂）方案治疗。主要终点是主要病理缓解（MPR）率。共纳入32例患者。中位年龄为60岁（范围：28-74岁），53.1%（17/32）的患者为Siewert III型。所有患者均接受了至少一个周期的指定术前治疗，93.8%（30/32）的患者完成了三个周期的指定术前替雷利珠单抗和SOX治疗。R0切除率为96.9%（31/32）。MPR、原发肿瘤的病理完全缓解（pCR）率和ypT0N0率分别为50.0%（16/32，95%CI：31.9-68.1%）、28.1%（9/32，95%CI：13.7-46.7%）和25.0%（8/32，95%CI：11.5-43.4%）。手术发病率为15.6%（5/32），未观察到30天死亡率。在术前和术后治疗期间，3-4级治疗相关不良事件的发生率为31.2%（10/32）。截至2025年1月7日，8例（25.0%）患者出现复发。因此，围手术期使用替雷利珠单抗联合化疗可显著改善病理退缩，可能是局部晚期可切除GEJA患者的一个有前景的选择。
