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Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma: A single-arm, multicenter, prospective study.

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收录情况： ◇ SCIE ◇ CSCD-C ◇ 卓越：梯队期刊

作者：
Ren-Yi Su [1] * ; Sun-Bin Ling [1] * ; Qiao-Nan Shan [2] ; Xu-Yong Wei [1] ; Rui Wang [1] ; Chang-Ku Jia [1] ; Li Zhuang [3] ; Tian Shen [4] ; Li-Min Ding [5] ; Zhi-Dan Xu [5] ; Lai-Bang Luo [5] ; Li-Bo Sun [6] ; Guang-Ming Li [6] ; Tai-Shi Fang [7] ; Nan Jiang [7] ; Kun Zhang [8] ; Zhao-Jie Su [8] ; Zhi-Hai Peng [8] ; Ren Lang [9] ; Tao Jiang [9] ; Qiang He [9] ; Lin-Sen Ye [10] ; Yang Yang [10] ; Yu-Ting He [11] ; Wen-Zhi Guo [11] ; Liu-Gen Lan [12] ; Xu-Yong Sun [12] ; Dong Chen [13] ; Zhi-Shui Chen [13] ; Da-Wei Zhou [14] ; Shao-Jun Ye [14] ; Qi-Fa Ye [14] ; Min Tian [15] ; Jian-Hua Shi [15] ; Bo Wang [15] ; Jiang Liu [16] ; Qian Lu [16] ; Wei Rao [17] ; Jin-Zhen Cai [17] ; Tao Lv [18] ; Jia-Yin Yang [18] ; Pu-Sen Wang [19] ; Lin Zhong [19] ; Jing-Sheng Ma [20] ; Qi-Gen Li [20] ; Sheng-Dong Wu [21] ; Chang-Jiang Lu [21] ; Cai-De Lu [21] ; Dong-Hua Zhang [22] ; Xuan Wang [22] ; Zi-Qiang Li [23] ; Mu-Jian Teng [23] ; Jun-Jie Li [24] ; Wen-Tao Jiang [24] ; Jian-Hua Li [25] ; Quan-Bao Zhang [25] ; Ning-Qi Zhu [25] ; Zheng-Xin Wang [25] ; Kang He [26] ; Qiang Xia [26] ; Shao-Hua Song [27] ; Zhi-Ren Fu [27] ; Wei Qiu [28] ; Guo-Yue Lv [28] ; Rui-Peng Song [29] ; Ji-Zhou Wang [29] ; Zheng Wang [30] ; Jian Zhou [30] ; Gang Chen [31] ; Ying-Peng Zhao [31] ; Li Li [31] ; Ze-Min Hu [32] ; Qi-Jie Luo [32] ; Zhong-Zhou Si [33] ; Bin Xie [33] ; Xiao-Shun He [34] ; Zhi-Yong Guo [34] ; Shu-Sen Zheng [2,3,4] ; Xiao Xu [1,2,4] ;
机构： [1]Department of Hepatobiliary and Pancreatic Surgery, The Center for Integrated Oncology and Precision Medicine, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China [2]NHC Key Laboratory of Combined Multi-organ Transplantation, Hangzhou 310003, China [3]Department of Hepatobiliary and Pancreatic Surgery, Shulan (Hangzhou) Hospital, Zhejiang Shuren University School of Medicine, Hangzhou 310022, China [4]Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China [5]Department of Transplantation, Jiangxi Provincial People’s Hospital Affiliated to Nanchang University, Nanchang 330006, China [6]Liver Transplantation Center, Beijing You’an Hospital, Capital Medical University, Beijing 100069, China [7]Department of Hepatic Surgery, National Clinical Research Center for Infectious Disease, Shenzhen Third People’s Hospital. The Second Affiliated Hospital of Southern University of Science and Technology, Shenzhen 518112, China [8]Department of General Surgery, Xiang’an Hospital of Xiamen University, Xiamen 361000, China [9]Deartment of Hepatobiliary and Pancreaticosplenic Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China [10]Department of Hepatic Surgery and Liver Transplantation Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China [11]Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China [12]Department of Liver Transplantation, The Second Affiliated Hospital of Guangxi Medical University, Nanning 530000, China [13]Institute of Organ Transplantation, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China [14]Institute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, Hubei Key Laboratory of Medical Technology on Transplantation, Zhongnan Hospital of Wuhan University, Wuhan 430071, China [15]Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China [16]Liver Transplantation Center, Tsinghua Changgung Hospital, Beijing 102218, China [17]Organ Transplantation Center, Affiliated Hospital of Qingdao University, 59 Haier Road, Laoshan District, Qingdao 266061, China [18]Department of Liver Surgery, Liver Transplantation Center, West China Hospital, Sichuan University, Chengdu 610044, China [19]Department of General Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China [20]Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang 330006, China [21]Department of Hepatobiliary and Pancreatic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo University, Ningbo 315041, China [22]Liver Transplant Center, General Hospital of Eastern Theater Command, Nanjing 210002, China [23]Department of General Surgery, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan 250014, China [24]Liver Transplant Department, Tianjin First Center Hospital, Tianjin 300192, China [25]Department of General Surgery, Huashan Hospital, Fudan University, Shanghai 200040, China [26]Department of Liver Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China [27]Liver Transplantaiton Center, Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China [28]Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun 130021, China [29]Department of Hepatobiliary Surgery, Anhui Province Key Laboratory of Hepatopancreatobiliary Surgery, The First Affiliated Hospital of USTC.Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, China [30]Department of Liver Surgery & Transplantation, Zhongshan Hospital Fudan University, Shanghai 200032, China [31]Department of hepato-biliary-pancreatic surgery and liver transplantation center, the First People’ s Hospital of Kunming, Kunming 650000, China [32]Department of Hepatobiliary Surgery, Zhongshan City People’s Hospital, Zhongshan 528499, China [33]Department of Liver Transplantation Center, The Second Xiangya Hospital of Central South University, Changsha 410011, China [34]Department of Hepatic Surgery and Liver Transplantation Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510062, China
出处：
DOI： 10.1016/j.hbpd.2021.09.001
ISSN：

摘要：
Mammalian target of rapamycin (mTOR) inhibitor as an attractive drug target with promising antitumor effects has been widely investigated. High quality clinical trial has been conducted in liver transplant (LT) recipients in Western countries. However, the pertinent studies in Eastern world are paucity. Therefore, we designed a clinical trial to test whether sirolimus can improve recurrence-free survival (RFS) in hepatocellular carcinoma (HCC) patients beyond the Milan criteria after LT. This is an open-labeled, single-arm, prospective, multicenter, and real-world study aiming to evaluate the clinical outcomes of early switch to sirolimus-based regimens in HCC patients after LT. Patients with a histologically proven HCC and beyond the Milan criteria will be enrolled. The initial immunosuppressant regimens are center-specific for the first 4-6 weeks. The following regimens integrated sirolimus into the regimens as a combination therapy with reduced calcineurin inhibitors based on the condition of patients and centers. The study is planned for 4 years in total with a 2-year enrollment period and a 2-year follow-up. We predict that sirolimus conversion regimen will provide survival benefits for patients particular in the key indicator RFS as well as better quality of life. If the trial is conducted successfully, we will have a continued monitoring over a longer follow-up time to estimate indicator of overall survival. We hope that the outcome will provide better evidence for clinical decision-making and revising treatment guidelines based on Chinese population data. Trial register: Trial registered at http://www.chictr.org.cn: ChiCTR2100042869.Copyright © 2021. Published by Elsevier B.V.

基金：
National S&T Ma- jor Project (2017ZX10203205), Key Program, National Natural Sci- ence Foundation of China ( 81930016 ) and Zhejiang Provincial Nat- ural Science Foundation of China (LY21H160026).
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2022]版：
大类 | 3 区 医学
小类 | 3 区 胃肠肝病学
最新[2023]版：
大类 | 3 区 医学
小类 | 4 区 胃肠肝病学
JCR分区：
出版当年[2021]版：
Q3 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版：
Q2 GASTROENTEROLOGY & HEPATOLOGY

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 Hepatobiliary and Pancreatic Surgery, The Center for Integrated Oncology and Precision Medicine, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Hepatobiliary and Pancreatic Surgery, The Center for Integrated Oncology and Precision Medicine, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China [2]NHC Key Laboratory of Combined Multi-organ Transplantation, Hangzhou 310003, China [3]Department of Hepatobiliary and Pancreatic Surgery, Shulan (Hangzhou) Hospital, Zhejiang Shuren University School of Medicine, Hangzhou 310022, China [4]Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
推荐引用方式(GB/T 7714)：
Ren-Yi Su,Sun-Bin Ling,Qiao-Nan Shan,et al.Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma: A single-arm, multicenter, prospective study.[J].HEPATOBILIARY & PANCREATIC DISEASES INTERNATIONAL.2022,21(2):106-112.doi:10.1016/j.hbpd.2021.09.001.
APA：
Ren-Yi Su,Sun-Bin Ling,Qiao-Nan Shan,Xu-Yong Wei,Rui Wang...&Xiao Xu.(2022).Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma: A single-arm, multicenter, prospective study..HEPATOBILIARY & PANCREATIC DISEASES INTERNATIONAL,21,(2)
MLA：
Ren-Yi Su,et al."Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma: A single-arm, multicenter, prospective study.".HEPATOBILIARY & PANCREATIC DISEASES INTERNATIONAL 21..2(2022):106-112

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