Zhao He, Zhang Xiaowu, Tian Pengfei, Luo Yingen, Sun Wei, Li Ying, Li Jingui, Gong Tao, Yang Zhengqiang, Song Peng, Li Xiao
Department of Interventional Therapy, National Cancer Center/National Clinical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital and Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, Guangdong, China.
BMJ Open. 2024 Dec 7;14(12):e080805. doi: 10.1136/bmjopen-2023-080805.
The exact role of hepatic arterial infusion chemotherapy (HAIC) in advanced hepatocellular carcinoma (aHCC) is still unknown. The combination of HAIC and sorafenib has been proven to be more effective than sorafenib alone in the first-line treatment of aHCC. The aim of the study is to evaluate the efficacy and safety of HAIC plus regorafenib in the second-line treatment of aHCC.
This is a multicenter, open-label, randomised controlled phase III trial. A total of 294 patients with aHCC, who are unable to tolerate the first-line systemic therapy or progress after the first-line systemic therapy, will be enrolled in the study. The patients will be randomly (2:1) assigned into the combination treatment group (HAIC plus regorafenib, n=196) and the control group (regorafenib alone, n=98). HAIC and regorafenib (160 mg/day) will be given in a 4-week cycle. The primary endpoint is overall survival in the intention-to-treat population. The second endpoints include progression-free survival, overall response rate, time to progression, etc. The radiological assessments will be based on the criteria of Response Evaluation Criteria in Solid Tumors 1.1.
This study is approved by the ethics committee of Cancer Hospital, Chinese Academy of Medical Sciences. All participants are required to provide written informed consent. The results of this study will be disseminated through peer-reviewed publications and esteemed academic conferences.
Chinese Clinical Trial Registry (ChiCTR2300073075).
肝动脉灌注化疗（HAIC）在晚期肝细胞癌（aHCC）中的确切作用尚不清楚。已证实HAIC与索拉非尼联合用于aHCC一线治疗比单独使用索拉非尼更有效。本研究的目的是评估HAIC联合瑞戈非尼用于aHCC二线治疗的疗效和安全性。
这是一项多中心、开放标签、随机对照III期试验。共有294例无法耐受一线全身治疗或一线全身治疗后进展的aHCC患者将纳入本研究。患者将被随机（2:1）分配到联合治疗组（HAIC联合瑞戈非尼，n = 196）和对照组（仅使用瑞戈非尼，n = 98）。HAIC和瑞戈非尼（160 mg/天）将按4周周期给药。主要终点是意向性治疗人群的总生存期。次要终点包括无进展生存期、总缓解率、进展时间等。影像学评估将基于实体瘤疗效评价标准1.1。
本研究已获得中国医学科学院肿瘤医院伦理委员会批准。所有参与者均需提供书面知情同意书。本研究结果将通过同行评审出版物和知名学术会议进行传播。
中国临床试验注册中心（ChiCTR2300073075）
