Department of Hepatobiliary Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Department of Hepatobiliary Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Clin Cancer Res. 2024 Jul 15;30(14):2937-2944. doi: 10.1158/1078-0432.CCR-24-0006.
This phase II, multicenter, prospective, single-arm study aimed to evaluate the efficacy and safety of toripalimab plus bevacizumab for treating advanced hepatocellular carcinoma (HCC).
Treatment-naïve patients with advanced HCC received toripalimab 240 mg plus bevacizumab 15 mg/kg every 3 weeks. The primary endpoints included safety and tolerability and objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Fifty-four patients were enrolled between April 17, 2020, and December 11, 2020. As assessed by the investigator according to RECIST v1.1, the ORR was 31.5% [95% confidence interval (CI), 19.5-45.6] and the lower bound of the 95% CI was above the prespecified boundary of 10%. The independent review committee (IRC) assessed ORR according to the modified RECIST (mRECIST), which was 46.3% (95% CI, 32.6-60.4). The median progression-free survival was 8.5 (95% CI, 5.5-11.0) and 9.8 months (95% CI, 5.6 to not evaluable) as assessed by the investigator according to RECIST v1.1 and IRC according to mRECIST criteria, respectively. The median overall survival (OS) was not reached, and the 12- and 24-month OS rates were 77.3% and 63.5%, respectively. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 27 patients (50.0%). The most common TEAEs were proteinuria (59.3%), hypertension (38.9%), increased aspartate aminotransferase (33.3%), increased amylase (29.6%), decreased platelet count (27.8%), and increased bilirubin levels (27.8%).
Toripalimab plus bevacizumab showed a favorable efficacy and safety profile, supporting further studies on this combination regimen as a first-line treatment for advanced HCC.
本 II 期、多中心、前瞻性、单臂研究旨在评估特瑞普利单抗联合贝伐珠单抗治疗晚期肝细胞癌（HCC）的疗效和安全性。
未经治疗的晚期 HCC 患者接受特瑞普利单抗 240mg 联合贝伐珠单抗 15mg/kg，每 3 周一次。主要终点包括安全性和耐受性以及研究者根据实体瘤反应评估标准 1.1（RECIST）评估的客观缓解率（ORR）。
2020 年 4 月 17 日至 2020 年 12 月 11 日期间，共纳入 54 例患者。根据 RECIST v1.1 标准，研究者评估的 ORR 为 31.5%[95%置信区间（CI）：19.5-45.6]，95%CI 的下限高于预设的 10%边界。独立审查委员会（IRC）根据改良 RECIST（mRECIST）评估的 ORR 为 46.3%（95%CI：32.6-60.4）。根据 RECIST v1.1，研究者评估的中位无进展生存期（PFS）为 8.5（95%CI：5.5-11.0），IRC 根据 mRECIST 标准评估的中位 PFS 为 9.8 个月（95%CI：5.6-不可评估）。中位总生存期（OS）未达到，12 个月和 24 个月 OS 率分别为 77.3%和 63.5%。27 例（50.0%）患者发生 3 级或以上治疗相关不良事件（TEAE）。最常见的 TEAE 是蛋白尿（59.3%）、高血压（38.9%）、天门冬氨酸氨基转移酶升高（33.3%）、淀粉酶升高（29.6%）、血小板计数降低（27.8%）和胆红素水平升高（27.8%）。
特瑞普利单抗联合贝伐珠单抗显示出良好的疗效和安全性，支持将该联合方案作为晚期 HCC 的一线治疗进行进一步研究。
