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安洛丁尼布与托里帕利马布结合,作为不可切除的肝细胞癌的第一线治疗:一项前性多中心II期研究

Cheng-Sheng Zhang¹, Zhi-Ming Zeng², Man-Yun Zhuo¹

¹Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical University, Haikou, People's Republic of China.

|June 17, 2023

概括

用anlotinib和toripalimab进行一线治疗证明了对不可切除的肝细胞癌 (HCC) 的有希望的疗效. 这种组合疗法为高级HCC患者提供了一种潜在的新方法,具有可控的安全性.

科学领域:

在瘤学瘤学.
医学研究医学研究
临床试验临床试验

背景情况:

不切除的肝细胞癌 (HCC) 具有有限的第一线治疗选择和不良的治疗结果.
对于先进的HCC,急需新且有效的治疗方法.

研究的目的:

评估anlotinib与toripalimab结合的疗效和安全性,作为不可切除的HCC的第一线治疗.
评估客观反应率 (ORR),疾病控制率 (DCR),反应持续时间 (DoR),无进展生存率 (PFS),总生存率 (OS) 和安全.

主要方法:

一项单臂,多中心的II期研究 (ALTER-H-003) 招募了患有晚期HCC的患者.
患者接受了anlotinib (12 mg在1至14天) 以及toripalimab (240 mg在1日) 每隔3周一次.
终点包括ORR (irRECIST/RECIST v1.1,mRECIST),DCR,DoR,PFS,OS,以及安全性评估等.

主要成果:

该ORR为29.0% (irRECIST/RECIST v1.1) 和32.3% (mRECIST). 这两种情况的相对比率是不同的.
确认的DCR为77.4%,中位数DoR没有达到.
中位数PFS为11.0个月,中位数OS为18.2个月. 常见的3级以上的副作用包括手脚综合征,高血压和关节痛.

结论:

安洛丁尼布加托利帕利马布在中国患者中表现出有希望的疗效和可控的安全性,患者患有不可切除的HCC.
这种组合疗法代表了对不可切除的HCC的潜在新疗法策略.

关键词:

安洛丁尼布的使用方法作为一线的治疗方法.肝细胞癌是肝细胞癌.在Toripalimab上使用.

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