在不可切除的肝细胞癌中使用Regorafenib加Nivolumab:第二阶段RENOBATE试验
Hyung-Don Kim1, Seyoung Jung2,3, Ho Yeong Lim4
1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Nature medicine
|February 20, 2024
概括
雷戈拉费尼布和尼沃卢马布的组合显示出在不可切除的肝细胞癌 (uHCC) 中具有有前途的抗瘤活性. 这种前线治疗满足了其主要终点,为HHCC患者提供了潜在的好处.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 雷戈拉菲尼布在不可切除的肝细胞癌 (uHCC) 中显示出抗瘤作用.
- 雷戈拉费尼布具有免疫调节特性,表明与免疫检查点抑制剂的协同作用.
- 结合疗法可能会改善HHCC患者的临床结果.
研究的目的:
- 评估前线regorafenib-nivolumab组合治疗HHCC的疗效和安全性.
- 确定客观响应率 (ORR) 作为主要终点.
- 探索生存结果和潜在的免疫反应生物标志物.
主要方法:
- 一个多中心,单臂,第二阶段试验 (RENOBATE) 涉及42名HHCC患者.
- 患者接受了尼沃卢马布 (480毫克每4周) 加上雷戈拉费尼布 (每天80毫克,3周/1周休息).
- 根据RECIST v1.1由研究人员评估的客观反应率 (ORR);安全性,PFS和OS是次要的终点. 进行了探索性单细胞RNA测序.
主要成果:
- 该研究满足了其主要终点,研究人员评估的ORR为31.0%每RECIST v1.1.1.
- 无进展生存期 (PFS) 的中位数为7.38个月.
- 一年整体存活率为80.5%,中位数未达到. 常见的不良事件包括手掌 - 脚掌红色素消散综合征,脱发和皮肤皮疹.
结论:
- 雷戈拉费尼布-尼沃卢马布组合是一种可行的HHCC前线治疗选择,显示出显著的抗瘤活性.
- 组合疗法显示了令人鼓舞的生存率和可管理的安全性.
- 探索性分析表明潜在的免疫生物标志物,包括与反应相关的T细胞受体多样化和M1单细胞两极化.
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