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Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma (CHANCE2201): a target trial emulation study

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作者：
Jin Zhi-Cheng[1,2] * ; Chen Jian-Jian[1,2] * ; Zhu Xiao-Li[3] * ; Duan Xu-Hua[4] * ; Xin Yu-Jing[5] * ; Zhong Bin-Yan[3] * ; Chen Jin-Zhang[6] * ; Tie Jun[7] * ; Zhu Kang-Shun[8] * ; Zhang Lan[9,10] * ; Huang Ming[11] * ; Piao Ming-Jian[12] * ; Li Xiao[13] ; Shi Hai-Bin[14] ; Liu Rui-Bao[15] ; Xu Ai-Bing[16] ; Ji Fanpu[17,18] ; Wu Jian-Bing[19] ; Shao Guo-Liang[20] ; Li Hai-Liang[21] ; Huang Ming-Sheng[22] ; Peng Zhi-Yi[23] ; Ji Jian-Song[24] ; Yuan Chun-Wang[25] ; Liu Xiu-Feng[26] ; Hu Zhou-Chao[27] ; Yang Wei-Zhu[28] ; Yin Guo-Wen[29] ; Huang Jin-Hua[30] ; Ge Nai-Jian[31] ; Qi Xiaolong[32] ; Zhao Yang[33] ; Zhou Jia-Wei[33] ; Xu Guo-Hui[34] ; Tu Qiang[35] ; Lin Hai-Lan[36] ; Zhang Yao-Jun[37,38] ; Jiang Hua[39] ; Shao Hai-Bo[40] ; Su Yong-Jie[41] ; Chen Ting-Song[42] ; Shi Bao-Qi[43] ; Zhou Xiang[13] ; Zhao Hai-Tao[12] ; Zhu Hai-Dong[1,2] ; Ren Zheng-Gang[9,10] ; Teng Gao-Jun[1,2] ;
机构： [1]Center of Interventional Radiology & Vascular Surgery, Nurturing Center of Jiangsu Province for State Laboratory of AI Imaging & Interventional Radiology (Southeast University), Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing, China. [2]State Key Laboratory of Digital Medical Engineering, National Innovation Platform for Integration of Medical Engineering Education (NMEE) (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Southeast University, Nanjing, China. [3]Department of Interventional Radiology, The First Affiliated Hospital of Soochow University, Soochow University, Suzhou, China. [4]Department of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China. [5]Department of Minimally Invasive Comprehensive Treatment of Cancer, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China. [6]State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. [7]National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi'an, China. [8]Department of Minimally Invasive Interventional Radiology and Radiology Center, and Minimally Invasive and Interventional Cancer Center, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [9]Department of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China. [10]Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education, Shanghai, China. [11]Department of Minimally Invasive Interventional Therapy, Yunnan Tumor Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming, China. [12]Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [13]Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [14]Department of Interventional Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. [15]Department of Interventional Radiology, The Tumor Hospital of Harbin Medical University, Harbin, China. [16]Department of Interventional Therapy, Nantong Tumor Hospital, Nantong, China. [17]Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [18]Key Laboratory of Environment and Genes Related to Diseases, Xi'an Jiaotong University, Ministry of Education of China, Xi'an, China. [19]Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China. [20]Intervention Department, Zhejiang Cancer Hospital, Hangzhou, China. [21]Department of Minimally Invasive Intervention, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. [22]Department of Interventional Radiology, The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China. [23]Hepatobiliary and Pancreatic Interventional Treatment Center, Division of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. [24]Department of Radiology, Key Laboratory of Imaging Diagnosis and Minimally Invasive Intervention Research, School of Medicine, Lishui Hospital of Zhejiang University, Lishui, China. [25]Center of Interventional Oncology and Liver Diseases, Beijing Youan Hospital, Capital Medical University, Beijing, China. [26]Department of Oncology, Nanjing Jinling Hospital of Nanjing University, Nanjing, China. [27]Interventional Diagnosis and Treatment Center, Zhoushan Hospital, Wenzhou Medical University, Wenzhou, China. [28]Department of Interventional Radiology, Union Hospital of Fujian Medical University, Fuzhou, China. [29]Department of Interventional Radiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & the Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. [30]Department of Minimally Invasive Interventional Therapy, Sun Yat-Sen University Cancer Center, Guangzhou, China. [31]Department of Interventional Radiology, Eastern Hospital of Hepatobiliary Surgery, Second Military Medical University, Shanghai, China. [32]Center of Portal Hypertension, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing, China. [33]Department of Biostatistics, Nanjing Medical University, Nanjing, China. [34]Department of Interventional Radiology, Sichuan Cancer Hospital and Institute, Chengdu, China. [35]Department of Hepatobiliary Oncology Surgery, Department of Interventional Oncology, Jiangxi Cancer Hospital of Nanchang University, Nanchang, China. [36]Department of Tumor Interventional Therapy, Fujian Cancer Hospital, Fuzhou, China. [37]State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China. [38]Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. [39]Cancer Treatment Centers, Second Affiliated Hospital of Kunming Medical University, Kunming, China. [40]Department of Interventional Radiology, The First Hospital of China Medical University, Shenyang, China. [41]Fujian Provincial Key Laboratory of Chronic Liver Disease and Hepatocellular Carcinoma, Xiamen Key Laboratory of Translational Medical of Digestive System Tumor, Department of Hepatobiliary Surgery, Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China. [42]Second Department of Oncology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China. [43]Department of Intervention, Inner Mongolia People's Hospital, Hohhot, China.
出处：
DOI： 10.1016/j.eclinm.2024.102622
ISSN：

关键词： Hepatocellular carcinoma Transarterial chemoembolization Immune checkpoint inhibitors Vascular endothelial growth factor Tyrosine kinase inhibitors Target trial emulation

摘要：
The role of transarterial chemoembolization (TACE) in the treatment of advanced hepatocellular carcinoma (HCC) is unconfirmed. This study aimed to assess the efficacy and safety of immune checkpoint inhibitors (ICIs) plus anti-vascular endothelial growth factor (anti-VEGF) antibody/tyrosine kinase inhibitors (TKIs) with or without TACE as first-line treatment for advanced HCC.This nationwide, multicenter, retrospective cohort study included advanced HCC patients receiving either TACE with ICIs plus anti-VEGF antibody/TKIs (TACE-ICI-VEGF) or only ICIs plus anti-VEGF antibody/TKIs (ICI-VEGF) from January 2018 to December 2022. The study design followed the target trial emulation framework with stabilized inverse probability of treatment weighting (sIPTW) to minimize biases. The primary outcome was overall survival (OS). Secondary outcomes included progression-free survival (PFS), objective response rate (ORR), and safety. The study is registered with ClinicalTrials.gov, NCT05332821.Among 1244 patients included in the analysis, 802 (64.5%) patients received TACE-ICI-VEGF treatment, and 442 (35.5%) patients received ICI-VEGF treatment. The median follow-up time was 21.1 months and 20.6 months, respectively. Post-application of sIPTW, baseline characteristics were well-balanced between the two groups. TACE-ICI-VEGF group exhibited a significantly improved median OS (22.6 months [95% CI: 21.2-23.9] vs 15.9 months [14.9-17.8]; P < 0.0001; adjusted hazard ratio [aHR] 0.63 [95% CI: 0.53-0.75]). Median PFS was also longer in TACE-ICI-VEGF group (9.9 months [9.1-10.6] vs 7.4 months [6.7-8.5]; P < 0.0001; aHR 0.74 [0.65-0.85]) per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. A higher ORR was observed in TACE-ICI-VEGF group, by either RECIST v1.1 or modified RECIST (41.2% vs 22.9%, P < 0.0001; 47.3% vs 29.7%, P < 0.0001). Grade ≥3 adverse events occurred in 178 patients (22.2%) in TACE-ICI-VEGF group and 80 patients (18.1%) in ICI-VEGF group.This multicenter study supports the use of TACE combined with ICIs and anti-VEGF antibody/TKIs as first-line treatment for advanced HCC, demonstrating an acceptable safety profile.National Natural Science Foundation of China, National Key Research and Development Program of China, Jiangsu Provincial Medical Innovation Center, Collaborative Innovation Center of Radiation Medicine of Jiangsu Higher Education Institutions, and Nanjing Life Health Science and Technology Project.© 2024 Published by Elsevier Ltd.

基金：
National Natural Science Foundation of China, National Key Research and Development Program of China, Jiangsu Provincial Medical Innovation Center, Collaborative Innovation Center of Radiation Medicine of Jiangsu Higher Education Institutions, and Nanjing Life Health Science and Technology Project.
语种：
外文
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出版当年[2024]版：
无
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[2024]版：
无
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[2023版]

第一作者：
第一作者机构： [1]Center of Interventional Radiology & Vascular Surgery, Nurturing Center of Jiangsu Province for State Laboratory of AI Imaging & Interventional Radiology (Southeast University), Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing, China. [2]State Key Laboratory of Digital Medical Engineering, National Innovation Platform for Integration of Medical Engineering Education (NMEE) (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Southeast University, Nanjing, China.
共同第一作者：
通讯作者：
通讯机构： [1]Center of Interventional Radiology & Vascular Surgery, Nurturing Center of Jiangsu Province for State Laboratory of AI Imaging & Interventional Radiology (Southeast University), Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing, China. [2]State Key Laboratory of Digital Medical Engineering, National Innovation Platform for Integration of Medical Engineering Education (NMEE) (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Southeast University, Nanjing, China. [9]Department of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China. [10]Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education, Shanghai, China.
推荐引用方式(GB/T 7714)：
Jin Zhi-Cheng,Chen Jian-Jian,Zhu Xiao-Li,et al.Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma (CHANCE2201): a target trial emulation study[J].ECLINICALMEDICINE.2024,72:102622.doi:10.1016/j.eclinm.2024.102622.
APA：
Jin Zhi-Cheng,Chen Jian-Jian,Zhu Xiao-Li,Duan Xu-Hua,Xin Yu-Jing...&Teng Gao-Jun.(2024).Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma (CHANCE2201): a target trial emulation study.ECLINICALMEDICINE,72,
MLA：
Jin Zhi-Cheng,et al."Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma (CHANCE2201): a target trial emulation study".ECLINICALMEDICINE 72.(2024):102622

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