Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A for Nonrandomized, Open-label, Phase II Trial
Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A for Nonrandomized, Open-label, Phase II Trial
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DOI：
10.1158/1078-0432.ccr-20-2571
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发表时间：
2021-02-15
影响因子：
11.5
通讯作者：
Wang, Quanren
中科院分区：
文献类型：
--
作者：
Xu, Jianming;Shen, Jie;Wang, Quanren
目的：我们评估了camrelizumab [一种抗程序性死亡（PD-1）单克隆抗体]加阿帕替尼（一种VEGFR-2酪氨酸激酶抑制剂）治疗晚期肝细胞癌（HCC）患者的疗效和安全性。患者和方法：这项非随机、开放标签、多中心、II期研究招募了初治或难治/不耐受一线靶向治疗的晚期HCC患者。接受静脉注射camrelizumab 200 mg（体重≥ 50 kg）或3 mg/kg（体重≥ 3 kg）的患者中，147/190例（77.4%）报告了治疗相关不良事件（TRAE），最常见的是高血压（34.2%）。55例（28.9%）患者发生严重TRAE。结论：Camrelizumab联合阿帕替尼在一线和二线治疗晚期HCC患者中显示出有希望的疗效和可管理的安全性。这可能是这些患者的一种新的治疗选择。
Purpose: We assessed the efficacy and safety of camrelizumab [an anti-programmed death (PD-1) mAb] plus apatinib (a VEGFR-2 tyrosine kinase inhibitor) in patients with advanced hepatocellular carcinoma (HCC).Patients and Methods: This nonrandomized, open-label, multicenter, phase II study enrolled patients with advanced HCC who were treatment-naive or refractory/intolerant to first-line targeted therapy. Patients received intravenous camrelizumab 200 mg (for bodyweight >= 50 kg) or 3 mg/kg (for bodyweight = 3 treatment-related adverse events (TRAE) were reported in 147 (77.4%) of 190 patients, with the most common being hypertension (34.2%). Serious TRAEs occurred in 55 (28.9%) patients. Two (1.1 %) treatment-related deaths occurred.Conclusions: Camrelizumab combined with apatinib showed promising efficacy and manageable safety in patients with advanced HCC in both the first-line and second-line setting. It might represent a novel treatment option for these patients.