Kurzfassung

A prospective randomized, open-labeled, trial comparing Sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma.

It will be an 8-year study (in total), consisting of a 3-year enrollment period with approximately 5-year follow-up. In principle, patients with a histologically confirmed HCC diagnosis will be randomized into 2 groups after liver transplantation. One group will be maintained for the study duration...
A prospective randomized, open-labeled, trial comparing Sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma.

It will be an 8-year study (in total), consisting of a 3-year enrollment period with approximately 5-year follow-up. In principle, patients with a histologically confirmed HCC diagnosis will be randomized into 2 groups after liver transplantation. One group will be maintained for the study duration on a center-specific mTOR-inhibitor-free immunosuppressive protocol. This control group of patients will be compared to a second group of patients that will be maintained on a center-specific mTOR-inhibitor-free immunosuppressive protocol for the first 4-6 weeks, at which time sirolimus will be incorporated into the regime either as a monotherapy, or as a combination therapy with non-mTOR-based immunosuppression. Our hypothesis is that
sirolimus use in the second arm of the study will improve the HCC-free survival in this liver transplant patient population. The study protocol will be conducted in compliance with the protocol, GCP, and all applicable regulatory requirements.» weiterlesen» einklappen