1. Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma: A single-arm, multicenter, prospective study.
- Author
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Su RY, Ling SB, Shan QN, Wei XY, Wang R, Jia CK, Zhuang L, Shen T, Ding LM, Xu ZD, Luo LB, Sun LB, Li GM, Fang TS, Jiang N, Zhang K, Su ZJ, Peng ZH, Lang R, Jiang T, He Q, Ye LS, Yang Y, He YT, Guo WZ, Lan LG, Sun XY, Chen D, Chen ZS, Zhou DW, Ye SJ, Ye QF, Tian M, Shi JH, Wang B, Liu J, Lu Q, Rao W, Cai JZ, Lv T, Yang JY, Wang PS, Zhong L, Ma JS, Li QG, Wu SD, Lu CJ, Lu CD, Zhang DH, Wang X, Li ZQ, Teng MJ, Li JJ, Jiang WT, Li JH, Zhang QB, Zhu NQ, Wang ZX, He K, Xia Q, Song SH, Fu ZR, Qiu W, Lv GY, Song RP, Wang JZ, Wang Z, Zhou J, Chen G, Zhao YP, Li L, Hu ZM, Luo QJ, Si ZZ, Xie B, He XS, Guo ZY, Zheng SS, and Xu X
- Subjects
- Humans, Immunosuppressive Agents adverse effects, Multicenter Studies as Topic, Neoplasm Recurrence, Local drug therapy, Prospective Studies, Quality of Life, Sirolimus adverse effects, Treatment Outcome, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular surgery, Liver Neoplasms drug therapy, Liver Neoplasms surgery, Liver Transplantation methods
- Abstract
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., Competing Interests: Competing interest No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article., (Copyright © 2021. Published by Elsevier B.V.)
- Published
- 2022
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