101. Efficacy and safety of sirolimus early conversion protocol in liver transplant patients with hepatocellular carcinoma: A single-arm, multicenter, prospective study
- Author
-
Mu-Jian Teng, Qiao-Nan Shan, Gang Chen, Tao Jiang, Nan Jiang, Da-Wei Zhou, Rui Wang, Lai-Bang Luo, Chang-Ku Jia, Yang Yang, Jin-Zhen Cai, Ren-Yi Su, Li Li, Ren Lang, Cai-De Lu, Shao-Jun Ye, Qiang He, Qifa Ye, Pusen Wang, Zhi-Ren Fu, Qiang Xia, Shao-Hua Song, Tao Lv, Kang He, Guoyue Lv, Li-Bo Sun, Wei Qiu, Ze-Min Hu, Zi-Qiang Li, Sheng-Dong Wu, Dong Chen, Jian-Hua Shi, Xiaoshun He, Quan-Bao Zhang, Zheng Wang, Jian Zhou, Min Tian, Ji-Zhou Wang, Lin-Sen Ye, Zhi-Hai Peng, Xuyong Wei, Wei Rao, Bo Wang, Rui-Peng Song, Sunbin Ling, Bin Xie, Yuting He, Qi-Gen Li, Wen-Zhi Guo, Lin Zhong, Jia-Yin Yang, Zhi-Dan Xu, Jing-Sheng Ma, Zhi-Yong Guo, Liu-Gen Lan, Tai-Shi Fang, Shusen Zheng, Xiao Xu, Qi-Jie Luo, Zhongzhou Si, Wen-tao Jiang, Zhao-Jie Su, Dong-Hua Zhang, Xu-Yong Sun, Kun Zhang, Li Zhuang, Ying-Peng Zhao, Zheng-Xin Wang, Xuan Wang, Jun-Jie Li, Jiang Liu, Guang-Ming Li, Ning-Qi Zhu, Zhishui Chen, Li-Min Ding, Tian Shen, Jian-Hua Li, Chang-Jiang Lu, and Qian Lu more...
- Subjects
Oncology ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Combination therapy ,medicine.medical_treatment ,Liver transplantation ,Milan criteria ,Internal medicine ,medicine ,Humans ,Multicenter Studies as Topic ,Prospective Studies ,Prospective cohort study ,Sirolimus ,Hepatology ,business.industry ,Liver Neoplasms ,Gastroenterology ,medicine.disease ,Liver Transplantation ,Clinical trial ,Regimen ,Treatment Outcome ,Hepatocellular carcinoma ,Quality of Life ,Neoplasm Recurrence, Local ,business ,Immunosuppressive Agents ,medicine.drug - 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. more...
- Published
- 2021