Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial
| Autor: | Enxiao Li, L Zhang, Jingfeng Liu, Guoliang Shao, Yun Zhang, Lihua Wu, Tao Yin, Guowen Yin, Zujiang Yu, Li Xu, Le-Qun Li, Zhanyu Pan, Zhenggang Ren, Jiayin Yang, Zhiming Wang, Jian-Ming Xu, Xianhai Mao, Yanqiao Zhang, Jianping Xiong, Kuansheng Ma, Quan Ren Wang, Xiaoming Chen, Xinmin Zhou, Jie Shen, Shuni Wang, Xi Chen, Shanzhi Gu, Kangsheng Gu, Jian Wu, Xiao Zhang |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Carcinoma Hepatocellular Pyridines Phases of clinical research Antibodies Monoclonal Humanized Gastroenterology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Refractory Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Medicine Apatinib Adverse effect Survival rate Response Evaluation Criteria in Solid Tumors business.industry Liver Neoplasms Middle Aged medicine.disease Progression-Free Survival Confidence interval Oncology chemistry 030220 oncology & carcinogenesis Hepatocellular carcinoma Cohort Female 030211 gastroenterology & hepatology business |
| Zdroj: | Clinical Cancer Research. 27:1003-1011 |
| ISSN: | 1557-3265 1078-0432 |
| Popis: | 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-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 Results: 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. 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. See related commentary by Pinato et al., p. 908 |
| Databáze: | OpenAIRE |
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