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

Su, Ren-Yi1; Ling, Sun-Bin1; Shan, Qiao-Nan2; Wei, Xu-Yong1; Wang, Rui1; Jia, Chang-Ku1; Zhuang, Li3; Shen, Tian4; Ding, Li-Min5; Xu, Zhi-Dan5; Luo, Lai-Bang5; Sun, Li-Bo6; Li, Guang-Ming6; Fang, Tai-Shi7,8; Jiang, Nan7,8; Zhang, Kun9; Su, Zhao-Jie9; Peng, Zhi-Hai9; Lang, Ren10; Jiang, Tao10; He, Qiang10; Ye, Lin-Sen11,12; Yang, Yang11,12; He, Yu-Ting13; Guo, Wen-Zhi13; Lan, Liu-Gen14; Sun, Xu-Yong14; Chen, Dong15; Chen, Zhi-Shui15; Zhou, Da-Wei16; Ye, Shao-Jun16; Ye, Qi-Fa16; Tian, Min17; Shi, Jian-Hua17; Wang, Bo17; Liu, Jiang18; Lu, Qian18; Rao, Wei19; Cai, Jin-Zhen19; Lv, Tao20; Yang, Jia-Yin20; Wang, Pu-Sen21; Zhong, Lin21; Ma, Jing-Sheng22; Li, Qi-Gen22; Wu, Sheng-Dong23; Lu, Chang-Jiang23; Lu, Cai-De23; Zhang, Dong-Hua24; Wang, Xuan24; Li, Zi-Qiang25,26; Teng, Mu-Jian25,26; Li, Jun-Jie27; Jiang, Wen-Tao27; Li, Jian-Hua28; Zhang, Quan-Bao28; Zhu, Ning-Qi28; Wang, Zheng-Xin28; He, Kang29; Xia, Qiang29; Song, Shao-Hua30; Fu, Zhi-Ren30; Qiu, Wei31; Lv, Guo-Yue31; Song, Rui-Peng32,33; Wang, Ji-Zhou32,33; Wang, Zheng34; Zhou, Jian34; Chen, Gang35,36; Zhao, Ying-Peng35,36; Li, Li35,36; Hu, Ze-Min37; Luo, Qi-Jie37; Si, Zhong-Zhou38; Xie, Bin38; He, Xiao-Shun39,40; Guo, Zhi-Yong39,40; Zheng, Shu-Sen2,3,4; Xu, Xiao1,2,4

2022-04-01

10.1016/j.hbpd.2021.09.001

Hepatobiliary & Pancreatic Diseases International   影响因子和分区

1499-3872

2352-9377

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 hepa-tocellular 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 popula-tion data. Trial register:Trial registered at http://www.chictr.org.cn: ChiCTR210 0 042869.(c) 2021 First Affiliated Hospital, Zhejiang University School of Medicine in China. Published by Elsevier B.V. All rights reserved.

Sirolimus Immunosuppressive agents Hepatocellular carcinoma Liver transplantation Conversion

SCI

英语

其他

National S&T Ma-jor Project[2017ZX10203205] ; Key Program, National Natural Sci-ence Foundation of China[81930016] ; Zhejiang Provincial Nat-ural Science Foundation of China[LY21H160026]

Gastroenterology & Hepatology

Gastroenterology & Hepatology

WOS:000798856600002

ELSEVIER

Web of Science

1.Zhejiang Univ, Affiliated Hangzhou Peoples Hosp 1, Dept Hepatobiliary & Pancreat Surg, Ctr Integrated Oncol & Precis Med,Sch Med, Hangzhou 310006, Peoples R China
2.NHC Key Lab Combined Multiorgan Transplantat, Hangzhou 310003, Peoples R China
3.Zhejiang Shuren Univ, Sch Med, Shulan Hangzhou Hosp, Dept Hepatobiliary & Pancreat Surg, Hangzhou 310022, Peoples R China
4.Zhejiang Univ, Sch Med, Affiliated Hosp 1, Dept Hepatobiliary & Pancreat Surg, Hangzhou 310003, Peoples R China
5.Nanchang Univ, Jiangxi Prov Peoples Hosp, Dept Transplantat, Nanchang 330006, Jiangxi, Peoples R China
6.Capital Med Univ, Beijing Youan Hosp, Liver Transplantat Ctr, Beijing 100069, Peoples R China
7.Southern Univ Sci & Technol, Natl Clin Res Ctr Infect Dis, Shenzhen Peoples Hosp 3, Dept Hepat Surg, Shenzhen 518112, Peoples R China
8.Southern Univ Sci & Technol, Affiliated Hosp 2, Shenzhen 518112, Peoples R China
9.Xiamen Univ, Xiangan Hosp, Dept Gen Surg, Xiamen 361000, Peoples R China
10.Capital Med Univ, Deartment Hepatobiliary & Pancreaticosplen Surg, Beijing Chaoyang Hosp, Beijing 100020, Peoples R China
11.Sun Yat Sen Univ, Affiliated Hosp 3, Dept Hepat Surg, Guangzhou 510630, Peoples R China
12.Sun Yat Sen Univ, Affiliated Hosp 3, Liver Transplantat Ctr, Guangzhou 510630, Peoples R China
13.Zhengzhou Univ, Affiliated Hosp 1, Dept Hepatobiliary & Pancreat Surg, Zhengzhou 450052, Peoples R China
14.Guangxi Med Univ, Affiliated Hosp 2, Dept Liver Transplantat, Nanning 530000, Peoples R China
15.Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Inst Organ Transplantat, Wuhan 430030, Peoples R China
16.Wuhan Univ, Hubei Key Lab Med Technol Transplantat, Inst Hepatobiliary Dis, Transplant Ctr,Zhongnan Hosp, Wuhan 430071, Peoples R China
17.Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Hepatobiliary Surg, Xian 710061, Peoples R China
18.Tsinghua Changgung Hosp, Liver Transplantat Ctr, Beijing 102218, Peoples R China
19.Qingdao Univ, Affiliated Hosp, Organ Transplantat Ctr, 59 Haier Rd, Qingdao 266061, Peoples R China
20.Sichuan Univ, West China Hosp, Liver Transplantat Ctr, Dept Liver Surg, Chengdu 610044, Peoples R China
21.Shanghai Jiao Tong Univ, Sch Med, Shanghai Gen Hosp, Dept Gen Surg, Shanghai 200080, Peoples R China
22.Nanchang Univ, Affiliated Hosp 2, Dept Hepatobiliary & Pancreat Surg, Nanchang 330006, Jiangxi, Peoples R China
23.Ningbo Univ, Ningbo Med Ctr Lihuili Hosp, Dept Hepatobiliary & Pancreat Surg, Ningbo 315041, Peoples R China
24.Gen Hosp Eastern Theater Command, Liver Transplant Ctr, Nanjing 210002, Peoples R China
25.Shandong First Med Univ, Affiliated Hosp 1, Dept Gen Surg, Jinan 250014, Peoples R China
26.Shandong Prov Qianfoshan Hosp, Jinan 250014, Peoples R China
27.Tianjin First Ctr Hosp, Liver Transplant Dept, Tianjin 300192, Peoples R China
28.Fudan Univ, Huashan Hosp, Dept Gen Surg, Shanghai 200040, Peoples R China
29.Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Dept Liver Surg, Shanghai 200127, Peoples R China
30.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Liver Transplantait Ctr,Dept Gen Surg, Shanghai 200025, Peoples R China
31.First Hosp Jilin Univ, Dept Hepatobiliary & Pancreat Surg, Changchun 130021, Peoples R China
32.Univ Sci & Technol China, Dept Hepatobiliary Surg, Anhui Prov Key Lab Hepatopancreatobiliary Surg, Affiliated Hosp USTC 1, Hefei 230001, Peoples R China
33.Univ Sci & Technol China, Div Life Sci & Med, Hefei 230001, Peoples R China
34.Fudan Univ, Zhongshan Hosp, Dept Liver Surg & Transplantat, Shanghai 200032, Peoples R China
35.First Peoples Hosp Kunming, Dept Hepatobiliarypancreat Surg, Kunming 650000, Yunnan, Peoples R China
36.First Peoples Hosp Kunming, Liver Transplantat Ctr, Kunming 650000, Yunnan, Peoples R China
37.Zhongshan City Peoples Hosp, Dept Hepatobiliary Surg, Zhongshan 528499, Peoples R China
38.Cent South Univ, Xiangya Hosp 2, Dept Liver Transplantat Ctr, Changsha 410011, Peoples R China
39.Sun Yat Sen Univ, Affiliated Hosp 1, Dept Hepat Surg, Guangzhou 510062, Peoples R China
40.Sun Yat Sen Univ, Affiliated Hosp 1, Liver Transplantat Ctr, Guangzhou 510062, Peoples R China

Su, Ren-Yi,Ling, Sun-Bin,Shan, Qiao-Nan,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).

Su, Ren-Yi.,Ling, Sun-Bin.,Shan, Qiao-Nan.,Wei, Xu-Yong.,Wang, Rui.,...&Xu, Xiao.(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).

Su, Ren-Yi,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).