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

Ren Yi Su, Sun Bin Ling, Qiao Nan Shan, Xu Yong Wei, Rui Wang, Chang Ku Jia, Li Zhuang, Tian Shen, Li Min Ding, Zhi Dan Xu, Lai Bang Luo, Li Bo Sun, Guang Ming Li, Tai Shi Fang, Nan Jiang, Kun Zhang, Zhao Jie Su, Zhi Hai Peng, Ren Lang, Tao JiangQiang He, Lin Sen Ye, Yang Yang, Yu Ting He, Wen Zhi Guo, Liu Gen Lan, Xu Yong Sun, Dong Chen, Zhi Shui Chen, Da Wei Zhou, Shao Jun Ye, Qi Fa Ye, Min Tian, Jian Hua Shi, Bo Wang, Jiang Liu, Qian Lu, Wei Rao, Jin Zhen Cai, Tao Lv, Jia Yin Yang, Pu Sen Wang, Lin Zhong, Jing Sheng Ma, Qi Gen Li, Sheng Dong Wu, Chang Jiang Lu, Cai De Lu, Dong Hua Zhang, Xuan Wang, Zi Qiang Li, Mu Jian Teng, Jun Jie Li, Wen Tao Jiang, Jian Hua Li, Quan Bao Zhang, Ning Qi Zhu, Zheng Xin Wang, Kang He, Qiang Xia, Shao Hua Song, Zhi Ren Fu, Wei Qiu, Guo Yue Lv, Rui Peng Song, Ji Zhou Wang, Zheng Wang, Jian Zhou, Gang Chen, Ying Peng Zhao, Li Li, Ze Min Hu, Qi Jie Luo, Zhong Zhou Si, Bin Xie, Xiao Shun He, Zhi Yong Guo, Shu Sen Zheng, Xiao Xu

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)106-112
Number of pages7
JournalHepatobiliary and Pancreatic Diseases International
Volume21
Issue number2
DOIs
StatePublished - Apr 2022

Keywords

  • Conversion
  • Hepatocellular carcinoma
  • Immunosuppressive agents
  • Liver transplantation
  • Sirolimus

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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