替雷利珠单抗联合瑞戈非尼治疗晚期肝细胞癌的疗效和安全性分析：一项前瞻性临床研究。
Analysis of efficacy and safety for the combination of tislelizumab and regorafenib in advanced hepatocellular carcinoma: A prospective clinical study.
机构信息
Department of Hepatobiliary Surgery, Shandong Cancer Hospital Affiliated to Shandong First Medical University, Huaiyin District, Jinan, China.
Department of Nephrology, People's Hospital of Shizhong District, Shizhong District, Jinan, China.
出版信息
J Cancer Res Ther. 2024 Aug 1;20(4):1344-1349. doi: 10.4103/jcrt.jcrt_2376_23. Epub 2024 Aug 29.
BACKGROUNDS
Programmed death receptor 1 (PD-1) monoclonal antibody has been approved for the first and second-line treatments of hepatocellular carcinoma (HCC). This study aimed to evaluate the efficacy and safety of tislelizumab + regorafenib as a second-line treatment option for advanced HCC.
METHODS
Treatment-related adverse events (TRAEs) were the primary endpoints in this clinical trial comprising 28 patients with advanced HCC. The secondary endpoints included objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).
RESULTS
According to the mRECIST 1.1 evaluation criteria, the ORR was 28.6%. Complete and partial response were observed in 3 and 5 patients, respectively; stable disease was observed in 12 patients (DCR, 71.4%). The median PFS was 6.4 months. The incidence of grade 1-2 and 3-4 TRAEs was 57.1% and 39.3%, respectively.
CONCLUSION
This study suggests that tislelizumab + regorafenib can be used as a second-line treatment for advanced HCC.
背景
程序性死亡受体 1（PD-1）单克隆抗体已被批准用于肝细胞癌（HCC）的一线和二线治疗。本研究旨在评估替雷利珠单抗+瑞戈非尼作为晚期 HCC 的二线治疗选择的疗效和安全性。
方法
本临床试验共纳入 28 例晚期 HCC 患者，以治疗相关不良事件（TRAEs）为主要终点。次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和无进展生存期（PFS）。
结果
根据 mRECIST 1.1 评估标准，ORR 为 28.6%。3 例患者完全缓解，5 例患者部分缓解；12 例患者疾病稳定（DCR，71.4%）。中位 PFS 为 6.4 个月。1-2 级和 3-4 级 TRAEs 的发生率分别为 57.1%和 39.3%。
结论
本研究表明，替雷利珠单抗+瑞戈非尼可作为晚期 HCC 的二线治疗选择。
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