在局部晚期MSI-H/dMMR结肠癌中IBI310加sintilimab的新辅助治疗:一个随机的1b期研究
Feng Wang1, Gong Chen1, Meng Qiu2
1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China.
Cancer cell
|October 3, 2025
概括
与抗CTLA-4和抗PD-1疗法的双免疫检查点抑制显著改善了与单疗法相比,局部晚期MSI-H/dMMR结肠癌的病理完整反应率.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 胃肠道癌症 胃肠道癌症
背景情况:
- 新辅助免疫疗法对局部发达的MSI-H/dMMR结肠癌具有前途.
- 双重免疫检查点抑制对抗PD-1单一治疗的好处尚未得到充分证实.
研究的目的:
- 评估新辅助抗CTLA-4 (IBI310) 加抗PD-1 (sintilimab) 与局部发达的MSI-H/dMMR结肠癌中的sintilimab单疗法相比的疗效和安全性.
主要方法:
- 随机阶段1b试验 (NCT05890742) 将IBI310 + 辛提利马布 (n=52) 与辛提利马布 (n=49) 相比较.
- 主要终点:病理完整反应 (pCR) 率.
- 二级终点包括安全性和疾病复发.
主要成果:
- 在组合手臂 (78.4%) 与单一治疗手臂 (46.7%) 的pCR率在mITT群体中显著更高 (p=0.0015).
- 在两只手臂中观察到可比和可管理的安全配置文件.
- 在中位数随访21.4个月后,没有报告疾病复发.
结论:
- 新辅助双免疫检查点抑制 (IBI310+sintilimab) 对局部发达的MSI-H/dMMR结肠癌的sintilimab单疗法提供了额外的好处.
- 组合治疗方案是安全有效的,具有有希望的长期结果.
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