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随机的II期研究比较了二线治疗高级肝细胞癌中的两剂雷戈拉费尼布

Keisuke Koroki¹, Sadahisa Ogasawara¹, Sae Yumita¹

¹Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.

JHEP reports : innovation in hepatology

|October 1, 2025

概括

雷戈拉费尼布对晚期肝细胞癌 (HCC) 患者具有多样化的治疗史是安全的. 探索性数据表明,标准剂量和减少剂量具有可比的疗效,支持个性化治疗策略.

科学领域:

肝胆细胞新生体的发生.
医学瘤学医学瘤学
临床药理学临床药理学

背景情况:

晚期肝细胞癌 (HCC) 的治疗选择有限,特别是在初始治疗后.
雷戈拉费尼布已被批准作为二线疗法,但其在不同先前治疗方法的患者中使用需要评估.
在REGAIN研究中,对超出RESORCE试验标准的患者进行了对regorafenib的评估.

研究的目的:

评估regorafenib在患有晚期HCC和多种治疗史的患者中的安全性和疗效.
为了比较标准 (160毫克/天) 与降低 (80毫克/天) 的开端剂量regorafenib.
为了评估regorafenib的耐受性和有效性,患者先前接受过sorafenib,lenvatinib或atezolizumab加bevacizumab治疗.

主要方法:

一个单中心,随机,开放标签,剂量比较试验.
晚期HCC患者在先前的全身治疗后接受了标准剂量或降低剂量的regorafenib.
安全性是通过第一周期中断与不良事件相关的停药来评估的; 根据进展时间 (TTP) 和 mRECIST来评估疗效.

主要成果:

纳入了36名患者;由于不良事件的早期中止是低的 (1/18在标准剂量组).
标准剂量中TTP的中位数为4.6个月,减少剂量为3.0个月 (p=0.810).
无进展生存率和总生存率在剂量组之间相似,两者的客观应答率为22.2%.

结论:

不管之前的治疗史,Regorafenib可以安全地给患有晚期HCC的患者使用.
探索性数据表明,标准剂量和降低的初始剂量之间具有可比的疗效.
需要进一步的研究来确认降低起始剂量的临床实用性,以优化先进的HCC治疗.

关键词:

肝细胞癌是肝细胞癌.在 RESORCE 试验中进行了试验.随机对照试验是随机对照试验.雷戈拉费尼布的使用情况

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