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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 |
| 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 , ... , Shu-Sen Zheng 2 , 3 , 4 , ∗ , Xiao Xu 1 , 2 , 4 , ∗ |
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
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∗Corresponding authors.
E-mail addresses: shusenzheng@zju.edu.cn (S.-S. Zheng), zjxu@zju.edu.cn (X. Xu).
# Contributed equally. |
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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.
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2022, Vol. 21 
