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Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study

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收录情况： ◇ SCIE

作者：
Qin Shukui[1] * ; Chan Stephen L[2] * ; Gu Shanzhi[3] ; Bai Yuxian[4] ; Ren Zhenggang[5] ; Lin Xiaoyan[6] ; Chen Zhendong[7] ; Jia Weidong[8] ; Jin Yongdong[9] ; Guo Yabing[10] ; Hu Xiaohua[11] ; Meng Zhiqiang[12] ; Liang Jun[13] ; Cheng Ying[14] ; Xiong Jianping[15] ; Ren Hong[16] ; Yang Fang[17] ; Li Wei[18] ; Chen Yajin[19] ; Zeng Yong[20] ; Sultanbaev Alexander[21] ; Pazgan-Simon Monika[22] ; Pisetska Margaryta[23] ; Melisi Davide[24] ; Ponomarenko Dmitriy[25] ; Osypchuk Yurii[26] ; Sinielnikov Ivan[27] ; Yang Tsai-Sheng[28] ; Liang Xiao[29] ; Chen Chunxia[29] ; Wang Linna[29] ; Cheng Ann-Lii[30] ; Kaseb Ahmed[31] ; Vogel Arndt[32] ;
机构： [1]Cancer Centre of Jinling Hospital, Nanjing University of Chinese Medicine and Nanjing Medical University, Nanjing, China. [2]State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China. [3]Department of Interventional Radiology, Hunan Cancer Hospital, Changsha, China. [4]Department of Gastroenterology, The Affiliated Tumor Hospital of Harbin Medical University, Harbin, China. [5]Department of Hepatic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China. [6]Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, China. [7]Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China. [8]Department of General Surgery, Anhui Provincial Hospital, Hefei, China. [9]Sichuan Cancer Hospital and Institute, Sichuan Cancer Centre, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China. [10]Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Liver Cancer Centre, Guangzhou, China. [11]Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. [12]Department of Integrative Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China. [13]Department of Medical Oncology, Peking University International Hospital, Beijing, China. [14]Department of Thoracic Oncology, Jilin Cancer Hospital, Jilin, China. [15]Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China. [16]Department for Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University and Institute for Viral Hepatitis, Chongqing Medical University, Chongqing, China. [17]Department of Hepatology, The Sixth People's Hospital of Shenyang, Shenyang, China. [18]Cancer Centre, The First Hospital of Jilin University, Jilin, China. [19]Department of Hepatobiliary Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China. [20]Department of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu, China. [21]Department of Antitumor Drug Therapy, Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan, Ufa, Russia. [22]Department of Infecious Disease and Hepatology, Wroclaw Medical University, Centrum Badan Klinicznych Piotr Napora, Wroclaw, Poland. [23]Department of Liver and Pancreas Gland Oncosurgery, Regional Centre of Oncology, Kharkiv, Ukraine. [24]Investigational Cancer Therapeutics Clinical Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy [26]Digestive Molecular Clinical Oncology Research Unit, University of Verona, Verona, Italy. [25]Department of Chemotherapy, State Budgetary Institution of Healthcare Regional Oncology Dispensary, Irkutsk, Russia. [26]Department of Surgery, Communal Non-commercial Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Odesa, Ukraine. [27]Department of Chemotherapy, The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council, Lutsk, Ukraine. [28]Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan. [29]Jiangsu Hengrui Pharmaceuticals, Shanghai, China. [30]Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan. [31]Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Centre, Houston, Texas, USA. [32]Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
出处：
DOI： 10.1016/S0140-6736(23)00961-3
ISSN：

摘要：
Immunotherapy with immune checkpoint inhibitors combined with an anti-angiogenic tyrosine-kinase inhibitor (TKI) has been shown to improve overall survival versus anti-angiogenic therapy alone in advanced solid tumours, but not in hepatocellular carcinoma. Therefore, a clinical study was conducted to compare the efficacy and safety of the anti-PD-1 antibody camrelizumab plus the VEGFR2-targeted TKI rivoceranib (also known as apatinib) versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma.This randomised, open-label, international phase 3 trial (CARES-310) was done at 95 study sites across 13 countries and regions worldwide. Patients with unresectable or metastatic hepatocellular carcinoma who had not previously received any systemic treatment were randomly assigned (1:1) to receive either camrelizumab 200 mg intravenously every 2 weeks plus rivoceranib 250 mg orally once daily or sorafenib 400 mg orally twice daily. Randomisation was done via a centralised interactive response system. The primary endpoints were progression-free survival, as assessed by the blinded independent review committee per Response Evaluation Criteria in Solid Tumours version 1.1, and overall survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of the study drugs. We report the findings from the prespecified primary analysis for progression-free survival and interim analysis for overall survival. This study is registered with ClinicalTrials.gov (NCT03764293).Between June 28, 2019, and March 24, 2021, 543 patients were randomly assigned to the camrelizumab-rivoceranib (n=272) or sorafenib (n=271) group. At the primary analysis for progression-free survival (May 10, 2021), median follow-up was 7·8 months (IQR 4·1-10·6). Median progression-free survival was significantly improved with camrelizumab-rivoceranib versus sorafenib (5·6 months [95% CI 5·5-6·3] vs 3·7 months [2·8-3·7]; hazard ratio [HR] 0·52 [95% CI 0·41-0·65]; one-sided p<0·0001). At the interim analysis for overall survival (Feb 8, 2022), median follow-up was 14·5 months (IQR 9·1-18·7). Median overall survival was significantly extended with camrelizumab-rivoceranib versus sorafenib (22·1 months [95% CI 19·1-27·2] vs 15·2 months [13·0-18·5]; HR 0·62 [95% CI 0·49-0·80]; one-sided p<0·0001). The most common grade 3 or 4 treatment-related adverse events were hypertension (102 [38%] of 272 patients in the camrelizumab-rivoceranib group vs 40 [15%] of 269 patients in the sorafenib group), palmar-plantar erythrodysaesthesia syndrome (33 [12%] vs 41 [15%]), increased aspartate aminotransferase (45 [17%] vs 14 [5%]), and increased alanine aminotransferase (35 [13%] vs eight [3%]). Treatment-related serious adverse events were reported in 66 (24%) patients in the camrelizumab-rivoceranib group and 16 (6%) in the sorafenib group. Treatment-related death occurred in two patients: one patient in the camrelizumab-rivoceranib group (ie, multiple organ dysfunction syndrome) and one patient in the sorafenib group (ie, respiratory failure and circulatory collapse).Camrelizumab plus rivoceranib showed a statistically significant and clinically meaningful benefit in progression-free survival and overall survival compared with sorafenib for patients with unresectable hepatocellular carcinoma, presenting as a new and effective first-line treatment option for this population.Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics.Copyright © 2023 Elsevier Ltd. All rights reserved.

基金：
This study was funded by Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics.
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出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Cancer Centre of Jinling Hospital, Nanjing University of Chinese Medicine and Nanjing Medical University, Nanjing, China.
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推荐引用方式(GB/T 7714)：
Qin Shukui,Chan Stephen L,Gu Shanzhi,et al.Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study[J].LANCET.2023,402(10408):1133-1146.doi:10.1016/S0140-6736(23)00961-3.
APA：
Qin Shukui,Chan Stephen L,Gu Shanzhi,Bai Yuxian,Ren Zhenggang...&Vogel Arndt.(2023).Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study.LANCET,402,(10408)
MLA：
Qin Shukui,et al."Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study".LANCET 402..10408(2023):1133-1146

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