Analysis of efficacy and safety for the combination of tislelizumab and regorafenib in advanced hepatocellular carcinoma: A prospective clinical study.

Journal of cancer research and therapeutics Pub Date : 2024-08-01 Epub Date: 2024-08-29 DOI:10.4103/jcrt.jcrt_2376_23

Pengfei Sun, Ying Zhang, Shilin Tian, Kai Cui, Jingtao Zhong, Chengsheng Zhang, Dongxu Wang, Bo Zhang, Xuetao Shi, Zhongchao Li

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Abstract

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.

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替赛珠单抗和瑞戈非尼联合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。

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。本研究旨在评估替斯利珠单抗+瑞戈非尼作为晚期HCC二线治疗方案的有效性和安全性：方法：在这项由28名晚期HCC患者参加的临床试验中，治疗相关不良事件（TRAEs）是主要终点。次要终点包括客观反应率（ORR）、疾病控制率（DCR）和无进展生存期（PFS）：根据 mRECIST 1.1 评估标准，ORR 为 28.6%。分别有 3 名和 5 名患者观察到完全和部分反应；12 名患者观察到疾病稳定（DCR，71.4%）。中位 PFS 为 6.4 个月。1-2级和3-4级TRAE的发生率分别为57.1%和39.3%：本研究表明，替斯利珠单抗+瑞戈非尼可作为晚期HCC的二线治疗方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of cancer research and therapeutics

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