IBI310加Sintilimab与安慰剂加Sintilimab在复发性/转移性子宫癌:一个双盲,随机对照试验
Huayi Li1, Yu Xu1, Xiaofei Jiao1
1National Clinical Research Center for Obstetrics and Gynecology, Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, China; Cancer Biology Research Center (Key Laboratory of the Ministry of Education, Hubei Provincial Key Laboratory of Tumor Invasion and Metastasis), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, China.
将CTLA-4阻断添加到PD-1/PD-L1治疗中并没有改善复发性/转移性宫癌 (R/M CC) 的结果. 该组合在反应率或生存率上没有显著差异,但增加了不良事件.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 结合CTLA-4阻断与PD-1/PD-L1阻断在宫癌 (CC) 的疗效仍在研究中.
- 复发性/转移性CC (R/M CC) 是一个重要的治疗挑战.
研究的目的:
- 评估在R/M CC.患者中添加IBI310 (CTLA-4阻断) 添加到sintilimab (PD-1/PD-L1阻断) 的疗效和安全性.
- 为了比较双免疫疗法与单剂PD-1/PD-L1阻塞.
主要方法:
- 一项随机,双盲,安慰剂控制的第二阶段研究 (NCT04590599) 招募了205名R/M CC患者.
- 患者接受了IBI310加Sintilimab或安慰剂加Sintilimab,然后仅服用Sintilimab.
- 主要终点是客观应答率 (ORR);次要终点包括无进展生存率 (PFS) 和整体生存率 (OS).
主要成果:
- IBI310-sintilimab的ORR为32.3%,与安慰剂-sintilimab的23.5%相比 (p = 0.17),没有显著差异.
- 中位数的PFS为3.6个月与4.2个月 (HR=0.91,p=0.58),中位数的OS为13.9个月与17.2个月 (HR=1.12,p=0.54).
- 与治疗相关的≥3级不良事件在组合组中更高 (55%对19%).
结论:
- 与单剂PD-1/PD-L1阻断相比,CTLA-4和PD-1/PD-L1的双重阻断没有显著改善R/M CC中的临床结果.
- 将IBI310添加到sintilimab并没有提高疗效终点.
- 在组合治疗中观察到毒性增加.
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