Cancer cell · 2026
Perioperative tislelizumab plus chemotherapy for locally advanced gastric cancer: A randomized, prospective phase 2 trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Xu Zhiyuan, Hu Can, Yang Litao, Yu Pengfei, Zhang Yanqiang, Chen Jiahui, Zheng Guoliang, Chen Xiaodong, Zhang Tao, He Weiyang, Meng Xiangyu, Yu Panpan, Du Yian, Liu Xiaowen, Liu Youdong, Wang Yongxiang, Wu Xiaoxiao, Pan Siwei, Zhang Ruolan, Zhang Shengjie, Xiong Zhirong, Sun Wei, Dong Chuanxin, Liu Jiajun, Wu Yuexian, Cheng Xiangdong
Аннотация
Perioperative immunotherapy improves outcomes in locally advanced gastric or gastroesophageal junction cancer (GC/GEJC), but reliable predictive biomarkers remain elusive. In this biomarker-stratified, randomized, multicenter phase 2 Mountain-02 trail (NCT06374901), 136 patients with operable cT3-4aN + M0 GC/GEJC were enrolled and stratified by tumor-specific MHC class II (tsMHC-II) expression status and then randomized (1:1) to receive perioperative tislelizumab plus chemotherapy or chemotherapy alone. Among tsMHC-II-positive patients, adding tislelizumab to chemotherapy significantly increased the major pathological response (mPR) rate compared with chemotherapy alone (61.8% vs. 26.5%, p = 0.003), meeting the pre-specified primary endpoint. In contrast, no significant benefit was observed in the tsMHC-II-negative subgroup. Within the combination therapy arm, tsMHC-II-positive patients also achieved numerically higher mPR (61.8% vs. 23.5%, p = 0.001) and higher pathological complete response (pCR) rate (32.4% vs. 5.9%, p = 0.006) than tsMHC-II-negative patients. These findings support tsMHC-II as a promising predictive biomarker for perioperative immunotherapy and warrant further validation in larger studies.