At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 525 enrolled
Drug / intervention
CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-Containing Versus mTOR-Inhibitor-Free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
In Brief
A Phase 3 clinical trial evaluating CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free) and Sirolimus for Hepatocellular Carcinoma. Completed, enrolled 525 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedJul 2006
Primary CompletionApr 2009
Study CompletionMay 2014
TodayJul 2026
First PostedJul 25, 2006
Enrollment StartJan 1, 2006
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.9 years ago
Interventions
CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)drug
center specific therapeutic regimen without mTOR inhibition
Sirolimusdrug
Sirolimus based immunosuppression