多纳芬尼与辛蒂利马布结合治疗晚期肝细胞癌:单臂II期试验
Xiaoyang Hong1,2, Yongjian Guo1, Wenbo Shi1,3
1Department of Minimally Invasive Interventional Radiology, the Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
BMC cancer
|February 5, 2025
概括
多纳费尼布与辛蒂利马布 (Don-Sin) 结合,对晚期肝细胞癌 (HCC) 显示出有前途的抗瘤作用. 这种组合疗法显示了6.2个月的中位数无进展生存期,具有可接受的安全性.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 肝细胞癌研究 肝细胞癌研究
背景情况:
- 以前的研究表明,抗血管原剂与免疫检查点抑制剂相结合,在不可切除的HCC中产生了令人鼓舞的结果.
- 多纳芬尼加辛蒂利马布 (Don-Sin) 正在研究用于先进的HCC治疗.
研究的目的:
- 为了调查donafenib与sintilimab联合治疗晚期肝细胞癌 (HCC) 的疗效和安全性.
主要方法:
- 一个单中心,单臂II期试验招募了患有BCLCC阶段C HCC的患者.
- 一个安全运行队列确定了经过剂量调整后的多纳芬尼 (200毫克每天一次) 与辛蒂利马布 (200毫克每3周一次) 结合的推剂量.
- 主要终点是根据修改的RECIST (mRECIST) 评估的无进展生存期 (PFS).
主要成果:
- 这项研究招募了30名患者,PFS的中位数为6.2个月 (mRECIST).
- 目标应答率为23.3% (mRECIST),疾病控制率达到76.7%.
- 平均整体存活时间为16.0个月,93.3%的人经历了与治疗相关的不良事件 (TRAE),其中30.0%的人患有3级TRAE.
结论:
- 在先进的HCC患者中,Don-Sin表现出有前途的抗瘤活性和可接受的安全性.
- 在第三阶段随机对照试验中需要进一步评估.
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