Transarterial Chemoembolization Combined With Camrelizumab and Rivoceranib for Unresectable Hepatocellular Carcinoma (CHANCE2005/CARES-005): A Randomized Phase II Trial
Abstract
PURPOSE Transarterial chemoembolization (TACE) alone has shown limited efficacy in improving survival among patients with unresectable hepatocellular carcinoma (HCC). This phase II trial compared TACE combined with camrelizumab (anti–PD-1 antibody) and rivoceranib (vascular endothelial growth factor receptor 2 inhibitor) versus TACE in unresectable HCC. METHODS Patients with unresectable HCC (Barcelona Clinic Liver Cancer stage A to C without extrahepatic metastases) and Child-Pugh class A liver function were randomly assigned (1:1), stratified by macrovascular invasion, previous tyrosine kinase inhibitor treatment, and number of previous TACE procedures, to receive TACE combined with camrelizumab (200 mg once every 3 weeks) and rivoceranib (250 mg once daily; TACE-C-R) or TACE alone. The primary end point was progression-free survival (PFS) per composite criteria (progression per Response Evaluation Criteria in Cancer of the Liver version 5, transient deterioration to Child-Pugh class C, or TACE failure or refractoriness) in the intention-to-treat population. RESULTS Between December 28, 2020, and October 29, 2023, 200 patients were randomly assigned (100 in each group). Median PFS per composite criteria was significantly longer with TACE-C-R than with TACE (10.8 months [95% CI, 8.8 to 13.7] v 3.2 months [95% CI, 2.4 to 4.2]; hazard ratio, 0.34 [95% CI, 0.24 to 0.50], P < .001). Grade ≥3 treatment-related adverse events occurred in 74.5% (70 of 94) of patients with TACE-C-R and 22.3% (23 of 103) of patients with TACE, with the most common being increased AST (29 [30.9%] and 13 [12.6%]) and increased ALT (23 [24.5%] and 14 [13.6%]). CONCLUSION The addition of camrelizumab and rivoceranib to TACE showed statistically significant improvement in PFS for patients with unresectable HCC, with a manageable safety profile. Follow-up for further overall survival analysis is ongoing.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (31)
Hai-Dong Zhu
Zhi-Cheng Jin, MD, PhD, Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China; Bin-Yan Zhong, MD, PhD, Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China; and Hai-Dong Zhu, MD, PhD, and Gao-Jun Teng, MD, PhD, Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China, Nurturing Center of Jiangsu Province for State Laboratory of AI Imaging & Interventional Radiology (Southeast University), Nanjing, China, Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Southeast University, Nanjing, China, State Key Laboratory of Digital Medical Engineering, Southeast University, Nanjing, China
Wei-Jun Fan
Department of Minimally Invasive Interventional Therapy, Liver Cancer Study and Service Group, Sun Yat-Sen University Cancer Center, Guangzhou, China
Chang Zhao
Song Wang
Yu-liang Li
Zhi-Cheng Jin
Zhi-Cheng Jin, MD, PhD, Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China; Bin-Yan Zhong, MD, PhD, Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China; and Hai-Dong Zhu, MD, PhD, and Gao-Jun Teng, MD, PhD, Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China, Nurturing Center of Jiangsu Province for State Laboratory of AI Imaging & Interventional Radiology (Southeast University), Nanjing, China, Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Southeast University, Nanjing, China, State Key Laboratory of Digital Medical Engineering, Southeast University, Nanjing, China
Zhe-Wei Zhang
Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China
Jin-He Guo
Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing, China
Hong-Tao Cheng
Qi Zhang
Jian Lu
Yong-Yi Zeng
Department of Hepatopancreatobiliary Surgery, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, China
Wei-Fu Lv
The First Affiliated Hospital of USTC, Anhui Provincial Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China
Hao Xu
Hai-Bo Shao
Department of Interventional Radiology, The First Hospital of China Medical University, Shenyang, China
Wei-Guo Xu
Zhuhai Interventional Medical Center, Zhuhai Precision Medical Center, Zhuhai People's Hospital, Zhuhai Hospital Affiliated with Jinan University, Zhuhai, China
Xu-Ya Zhao
Department of Interventional Radiology, Guizhou Cancer Hospital, Guiyang, China
Shan-Zhi Gu
Department of Interventional Radiology, Hunan Cancer Hospital, Changsha, China
Hai-Lan Lin
Department of Interventional Oncology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, China
Wen-Heng Zheng
Department of Medical Imaging, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China
Long-Zhen Piao
Department of Oncology, The Affiliated Hospital of Yanbian University, Yanji, China
Yu-Sheng Song
Department of Interventional Radiology, Ganzhou People's Hospital, Ganzhou, China
Jian-Bo Zhao
Interventional Department, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China
Yuan-Cheng Wang
National Innovation Platform for Integration of Medical Engineering Education (NMEE) (Southeast University), Southeast University, Nanjing, China
Zhi-Guo Hou
Department of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China
Ying Sun
Ni Guan
Ming Huang
Wei-Zhu Yang
Department of Interventional Radiology, Union Hospital of Fujian Medical University, Fuzhou, China
Jian-Song Ji
Department of Radiology, Key Laboratory of Imaging Diagnosis and Minimally Invasive Intervention Research, School of Medicine, Lishui Hospital of Zhejiang University, Lishui, China
Gao-Jun Teng
Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, School of Medicine, Southeast University