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Camrelizumab in combination with apatinib in patients with advanced hepatocellular carcinoma (RESCUE): a non-randomized, open-label, phase 2 trial.

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作者：
Xu Jianming[1,*1] ; Shen Jie[2] ; Gu Shanzhi[3] ; Zhang Yun[1] ; Wu Lihua[4] ; Wu Jian[4] ; Shao Guoliang[5] ; Zhang Yanqiao[6] ; Xu Li[7] ; Yin Tao[8] ; Liu Jingfeng[9] ; Ren Zhenggang[10] ; Xiong Jianping[11] ; Mao Xianhai[12] ; Zhang Ling[13] ; Yang Jiayin[14] ; Li Le-Qun[15] ; Chen Xiaoming[16] ; Wang Zhiming[17] ; Gu Kangsheng[18] ; Chen Xi[19] ; Pan Zhanyu[20] ; Ma Kuansheng[21] ; Zhou Xinmin[22] ; Yu Zujiang[23] ; Li Enxiao[24] ; Yin Guowen[25] ; Zhang Xiao[26] ; Wang Shuni[26] ; Wang Quan Ren[26] ;
机构： [1]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China [2]Department of Oncology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China [3]Radioactive Interventional Department, Hunan Cancer Hospital, Changsha, China [4]Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China [5]Intervention Therapy Department, Zhejiang Cancer Hospital, Hangzhou, China [6]Department of Gastrointestinal Medical Oncology， Harbin Medical University Cancer Hospital, Harbin, China [7]Hepatobiliary and Pancreatic Surgery, Sun Yat- Sen University Cancer Center, Guangzhou, China [8]Department of Hepatic & Biliary & Pancreatic Surgery, Hubei Cancer Hospital, Affiliated Hubei Cancer Hospital of Huazhong University of Science and Technology, Wuhan, China [9]Liver Department, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, China [10]Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China [11]Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China [12]Liver Surgery, Hunan People's Hospital, Changsha, China [13]Hepatobiliary surgery, Henan Cancer Hospital, Zhengzhou, China [14]Liver Transplantation Center, Department of Liver Surgery, West China Hospital of Sichuan University, Chengdu, China [15]Department of Hepatobiliary Surgery, Guangxi Medical University Affiliated Tumor Hospital, Nanning, China [16]Department of Interventional Radiology, Cancer Center, Guangdong Provincial [17]General Surgery, Liver & Thyroid Surgery, Xiangya Hospital Central South University, Changsha, China [18]Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China [19]Medical Oncology, 900 Hospital of the Joint Logistics Support Force, Fuzhou, China [20]Department of Integrated Chinese and Western Medicine， Tianjin Medical University Cancer Institute and Hospital, Tianjin, China [21]Hepatobiliary Surgery, The First Hospital Affiliated to AMU, Chongqing, China [22]Digestive Department, The First Affiliated Hospital of The Fourth Military Medical University, Xian, China [23]Infectious Disease, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China [24]Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China [25]Interventional Department, Jiangsu Cancer Hospital, Nanjing, China [26]Clinical Research & Development, Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China
出处：
DOI： 10.1158/1078-0432.CCR-20-2571
ISSN：

摘要：
We assessed the efficacy and safety of camrelizumab (an anti-PD-1 monoclonal antibody) plus apatinib (a vascular endothelial growth factor [VEGFR]-2 tyrosine kinase inhibitor) in patients with advanced hepatocellular carcinoma (HCC). This non-randomized, open-label, multicenter, phase 2 study enrolled patients with advanced HCC who were treatment-naive or refractory/intolerant to first-line targeted therapy. Patients received intravenous camrelizumab 200 mg (for bodyweight ≥50 kg) or 3 mg/kg (for bodyweight <50 kg) every 2 weeks plus oral apatinib 250 mg daily. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC) per RECIST v1.1. 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% 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 (TRAEs) 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. 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. Copyright ©2020, American Association for Cancer Research.

基金：
This work was supported by Jiangsu Hengrui Medicine Co., Ltd.
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外文
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出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2021]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China [*1]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, No. 8 East Street, Fengtai District, Beijing 100071, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China [*1]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, No. 8 East Street, Fengtai District, Beijing 100071, China
推荐引用方式(GB/T 7714)：
Xu Jianming,Shen Jie,Gu Shanzhi,et al.Camrelizumab in combination with apatinib in patients with advanced hepatocellular carcinoma (RESCUE): a non-randomized, open-label, phase 2 trial.[J].CLINICAL CANCER RESEARCH.2021,27(4):1003-1011.doi:10.1158/1078-0432.CCR-20-2571.
APA：
Xu Jianming,Shen Jie,Gu Shanzhi,Zhang Yun,Wu Lihua...&Wang Quan Ren.(2021).Camrelizumab in combination with apatinib in patients with advanced hepatocellular carcinoma (RESCUE): a non-randomized, open-label, phase 2 trial..CLINICAL CANCER RESEARCH,27,(4)
MLA：
Xu Jianming,et al."Camrelizumab in combination with apatinib in patients with advanced hepatocellular carcinoma (RESCUE): a non-randomized, open-label, phase 2 trial.".CLINICAL CANCER RESEARCH 27..4(2021):1003-1011

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