He Jiaxing, Zhang Bo, Zhou Shuai, Yang Ying, Han Zhuo, Wu Tao, Qiao Qing, Yang Haicheng, He Xianli, Wang Nan
Department of General Surgery, Air Force Medical University Tangdu Hospital, Xi'an, China.
Cancer Sci. 2025 Mar;116(3):736-743. doi: 10.1111/cas.16425. Epub 2024 Dec 10.
Immune checkpoint inhibitors combined with chemotherapy have shown promising efficacy in treating gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in the neoadjuvant setting. This phase II trial (NCT05715632) aimed to investigate the efficacy and safety of perioperative camrelizumab plus XELOX in patients with locally advanced G/GEJ adenocarcinoma. Treatment-naive patients with cT3-4aN1-3 M0 resectable locally advanced G/GEJ adenocarcinoma were recruited to receive camrelizumab (200 mg, intravenously) on Day 1 combined with XELOX (oxaliplatin at 130 mg/m on Day 1 and capecitabine at 1000 mg/m on Days 1-14) every 3 weeks for four cycles, followed by surgery and adjuvant camrelizumab combined with XELOX every 3 weeks for four cycles. The primary endpoint was the pathological complete response (pCR; ypT0N0) rate. From September 2020 to January 2023, 46 patients were enrolled, and all patients completed neoadjuvant therapy. Among them, 43 underwent D2 resection. In the intention-to-treat population, pCR was achieved in nine patients (19.6%, 95% confidence interval [CI]: 9.9%-34.4%), and the major pathological response was achieved in 25 patients (54.3%, 95% CI: 39.2%-68.8%). The objective response rate was 69.6%, of which 12 patients achieved a complete response and 20 patients achieved a partial response. The 1-year event-free survival and disease-free survival rates were both 93.1%. Treatment-related adverse events (TRAEs) occurred in 42 (91.3%) patients, and grade 3 TRAEs occurred in nine (19.6%) patients. No grades 4-5 TRAEs were observed. Perioperative camrelizumab combined with XELOX showed promising pathological response with an acceptable safety profile in patients with resectable locally advanced G/GEJ adenocarcinoma.
免疫检查点抑制剂联合化疗在新辅助治疗胃或胃食管交界（G/GEJ）腺癌方面已显示出有前景的疗效。这项II期试验（NCT05715632）旨在研究围手术期卡瑞利珠单抗联合XELOX方案治疗局部晚期G/GEJ腺癌患者的疗效和安全性。招募未经治疗的cT3-4aN1-3 M0可切除局部晚期G/GEJ腺癌患者，在第1天接受卡瑞利珠单抗（200 mg，静脉注射）联合XELOX方案（第1天奥沙利铂130 mg/m²，第1 - 14天卡培他滨1000 mg/m²），每3周一次，共四个周期，随后进行手术，术后辅助卡瑞利珠单抗联合XELOX方案，每3周一次，共四个周期。主要终点是病理完全缓解（pCR；ypT0N0）率。从2020年9月至2023年1月，共纳入46例患者，所有患者均完成新辅助治疗。其中，43例患者接受了D2根治性切除术。在意向性分析人群中，9例患者达到pCR（19.6%，95%置信区间[CI]：9.9% - 34.4%），25例患者达到主要病理缓解（54.3%，95% CI：39.2% - 68.8%）。客观缓解率为69.6%，其中12例患者达到完全缓解，20例患者达到部分缓解。1年无事件生存率和无病生存率均为93.1%。42例（91.3%）患者发生治疗相关不良事件（TRAEs），9例（19.6%）患者发生3级TRAEs。未观察到4 - 5级TRAEs。围手术期卡瑞利珠单抗联合XELOX方案在可切除局部晚期G/GEJ腺癌患者中显示出有前景的病理反应，且安全性可接受。
