Details

Autor(en) / Beteiligte

• Xu, Jianming
• Shen, Jie
• Gu, Shanzhi
• Zhang, Yun
• Wu, Lihua
• Wu, Jian
• Shao, Guoliang
• Zhang, Yanqiao
• Xu, Li
• Yin, Tao
• Liu, Jingfeng
• Ren, Zhenggang
• Xiong, Jianping
• Mao, Xianhai
• Zhang, Ling
• Yang, Jiayin
• Li, Lequn
• Chen, Xiaoming
• Wang, Zhiming
• Gu, Kangsheng
• Chen, Xi
• Pan, Zhanyu
• Ma, Kuansheng
• Zhou, Xinmin
• Yu, Zujiang
• Li, Enxiao
• Yin, Guowen
• Zhang, Xiao
• Wang, Shuni
• Wang, Quanren

Titel

Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial

Ist Teil von

• Clinical cancer research, 2021-02, Vol.27 (4), p.1003-1011

Ort / Verlag

United States

Erscheinungsjahr

2021

Quelle

Electronic Journals Library

Beschreibungen/Notizen

• 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). This nonrandomized, open-label, multicenter, phase II study enrolled patients with advanced HCC who were treatment-naïve or refractory/intolerant to first-line targeted therapy. Patients received intravenous camrelizumab 200 mg (for bodyweight ≥50 kg) or 3 mg/kg (for bodyweight <50 kg) every 2 weeks plus oral apatinib 250 mg daily. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC) per RECIST v1.1. Seventy patients in the first-line setting and 120 patients in the second-line setting were enrolled. As of January 10, 2020, the ORR was 34.3% [24/70; 95% confidence interval (CI), 23.3-46.6] in the first-line and 22.5% (27/120; 95% CI, 15.4-31.0) in the second-line cohort per IRC. Median progression-free survival in both cohorts was 5.7 months (95% CI, 5.4-7.4) and 5.5 months (95% CI, 3.7-5.6), respectively. The 12-month survival rate was 74.7% (95% CI, 62.5-83.5) and 68.2% (95% CI, 59.0-75.7), respectively. Grade ≥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. 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. .