卡瑞利珠单抗联合SOX化疗作为Ⅲ期胃或胃食管交界腺癌的辅助治疗：一项前瞻性、多中心、单臂、Ⅱ期试验。

Camrelizumab plus SOX chemotherapy as adjuvant therapy for pathological stage III gastric or gastroesophageal junction adenocarcinoma: a prospective, multicenter, single-arm, phase II trial.

作者信息

Jin Hailong, Yu Jiren, Gao Yuan, Liu Xiaosun, Xu Hongtao, Jiang Haiping, Zhou Shenkang, Xu Nong, Zheng Yulong, Shen Qianyun, Zhao Zhicheng, Wu Dan, Zhang Qing, Zhu Kankai

机构信息

Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Qingchun Road No. 79, Hangzhou 310006, China.

出版信息

Ther Adv Med Oncol. 2025 Jul 10;17:17588359251355781. doi: 10.1177/17588359251355781. eCollection 2025.

DOI:10.1177/17588359251355781

PMID:40656603

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12254632/

Abstract

BACKGROUND

Immune checkpoint inhibitors have shown promising results in the treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

OBJECTIVES

To evaluate the safety and efficacy of camrelizumab combined with S-1 plus oxaliplatin chemotherapy in the postoperative setting for pathological stage III (pStage III) G/GEJ adenocarcinoma.

DESIGN

This study was a prospective, multicenter, single-arm, phase II trial.

METHODS

Patients with pStage III G/GEJ adenocarcinoma were enrolled, receiving camrelizumab (200 mg), followed by oxaliplatin (130 mg/m), both administered on day 1 of each 21-day cycle, and tegafur-gimeracil-oteracil potassium capsules (40-60 mg, twice daily) for 2 weeks, followed by a 7-day rest period. A total of eight treatment cycles were planned. The primary endpoints were the incidence of any-grade and grade 3 or 4 adverse events. The secondary endpoints were disease-free survival (DFS), overall survival (OS), and treatment completion rate.

RESULTS

Between September 2020 and March 2023, 52 patients were enrolled at three medical centers in Zhejiang Province, China. All 52 patients (100%) experienced treatment-related adverse events (TRAEs). Grade 3 or higher TRAEs were reported in 35 patients (67.3%). Events occurring in >10% of the patients included decreased neutrophil count, neutropenia, leukopenia, thrombocytopenia, and anemia. Eleven (21.2%) patients experienced TRAEs that led to the interruption or discontinuation of camrelizumab, including rash (1), hypothyroidism (1), hyperkalemia (1), interstitial pneumonia (2), cystitis or urethritis (2), and reactive cutaneous capillary endothelial proliferation (4). The actual 2-year DFS and OS rates were 82.4% and 86.3%, respectively, whereas the estimated 3-year DFS and OS rates were 69.1% and 71.3%, respectively.

CONCLUSION

Camrelizumab combined with chemotherapy has a manageable and tolerable safety profile as an adjuvant treatment for pStage III G/GEJ adenocarcinoma. However, careful patient selection is necessary to identify patients most likely to benefit from combination therapy.

TRIAL REGISTRATION

ClinicalTrials.gov registry: NCT04515615; Date of registration: August 14, 2020; Weblink: https://clinicaltrials.gov/study/NCT04515615.

摘要

背景

免疫检查点抑制剂在晚期胃癌或胃食管交界（G/GEJ）腺癌的治疗中已显示出有前景的结果。

目的

评估卡瑞利珠单抗联合S-1加奥沙利铂化疗在术后病理III期（pIII期）G/GEJ腺癌中的安全性和疗效。

设计

本研究是一项前瞻性、多中心、单臂、II期试验。

方法

纳入pIII期G/GEJ腺癌患者，接受卡瑞利珠单抗（200mg），随后接受奥沙利铂（130mg/m²），均在每21天周期的第1天给药，替吉奥胶囊（40 - 60mg，每日两次）给药2周，随后休息7天。共计划进行8个治疗周期。主要终点是任何级别的和3级或4级不良事件的发生率。次要终点是无病生存期（DFS）、总生存期（OS）和治疗完成率。

结果

2020年9月至2023年3月，中国浙江省的三个医疗中心共纳入52例患者。所有52例患者（100%）均经历了治疗相关不良事件（TRAEs）。35例患者（67.3%）报告了3级或更高等级的TRAEs。发生率超过10%的事件包括中性粒细胞计数减少、中性粒细胞减少、白细胞减少、血小板减少和贫血。11例（21.2%）患者经历了导致卡瑞利珠单抗中断或停用的TRAEs，包括皮疹（1例）、甲状腺功能减退（1例）、高钾血症（1例）、间质性肺炎（2例）、膀胱炎或尿道炎（2例）以及反应性皮肤毛细血管内皮增殖（4例）。实际2年DFS率和OS率分别为82.4%和86.3%，而估计3年DFS率和OS率分别为69.1%和71.3%。