Phase 3
N=70
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
Liver Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00328770 ↗Enrolled (actual)
70
Serious AEs
10.0%
Results posted
Oct 2012
Primary outcome: Primary: Percentage of Participants Surviving at One and Four Years After Liver Transplant — 85; 77 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Mar 2006
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 | — |
Summary
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.
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.