Phase 3
Completed N=70
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
Source: ClinicalTrials.gov NCT00328770 ↗Enrolled (actual)
70
Serious AEs
10.0%
Results posted
Oct 2012
Primary outcomePrimary: Percentage of Participants Surviving at One and Four Years After Liver Transplant — 85; 77 percentage of participants
Summary
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Surviving at One and Four Years After Liver Transplant |
85; 77 | — |
| PRIMARY Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant |
84; 74 | — |
| SECONDARY Sirolimus Toxicity/Intolerance |
13 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant
Exclusion criteria
- Patients less than 18 years of age
Data sourced from ClinicalTrials.gov (NCT00328770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.