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伦瓦提尼布,辛蒂利马布加上通过动脉的化学栓塞治疗晚期肝细胞癌:一项II期研究

Mingyue Cai^1,2,3, Wensou Huang^1,2,3, Wei Liang^1,2,4

¹Department of Minimally Invasive Interventional Radiology, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

Liver international : official journal of the International Association for the Study of the Liver

|January 31, 2024

概括

这一II期试验表明,伦瓦提尼布,辛蒂利马布 (PD-1抑制剂) 和跨动脉化血栓化 (TACE) 联合治疗 (伦-辛-TACE) 对晚期肝细胞癌 (HCC) 显示出有前途的抗瘤活性. 治疗实现了8.0个月的中位数无进展生存期,并具有可管理的安全性.

科学领域:

肝胆道恶性瘤肝胆道恶性瘤
在瘤学瘤学.
临床试验临床试验

背景情况:

晚期肝细胞癌 (HCC) 是一个重大的临床挑战.
之前的回顾性研究表明,将伦瓦替尼与PD-1抑制剂和TACE结合起来有好处.
需要进行前性调查来证实这些发现.

研究的目的:

为了前性地评估lenvatinib,sintilimab (一种PD-1抑制剂),以及在先进的HCC患者中进行的跨动脉化学栓塞 (TACE) 的疗效和安全性.
确定无进展生存期 (PFS) 作为主要终点.
评估反应率,反应持续时间,整体存活率和与治疗相关的不良事件.

主要方法:

进行了一项单臂II期临床试验.
纳入了巴塞罗那诊所肝癌 (BCLC) 阶段C HCC的患者.
治疗包括每天口服伦瓦提尼布,每3周内静脉注射辛蒂利马布和TACE按需,以每次mRECIST的PFS为主要终点.

主要成果:

每个mRECIST的PFS中位数为8.0个月 (95% CI:6.1-9.8).
目标应答率为60.0% (mRECIST),疾病控制率为86.7%.
平均整体存活时间达到18.4个月 (95%CI:14.5-22.3),其中93.3%经历了与治疗相关的不良事件 (TRAE),其中40.0%患有3级TRAE.

结论:

伦-辛-TACE组合疗法在晚期HCC中表现出有前途的抗瘤活性.
这种治疗表现出可管理的安全性.
建议通过III期随机试验进行进一步验证.

关键词:

肝细胞癌是肝细胞癌.伦瓦提尼布 (Lenvatinib) 是一种药物.编程死亡 1 抑制剂这种感觉是不可思议的.通过动脉的化学栓塞.

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