Clinical trial · Interventional
Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation
Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation: A Multicenter, Open-label, Randomized, Controlled Clinical Trial in Liver Transplant Recipients With Hepatocellular Carcinoma
NCT03500848CI-TRIAL-00032554unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, open-label, randomized, controlled clinical trial, in order to compare sirolimus-based (tacrolimus-free) versus tacrolimus-based (sirolimus-free) immunosuppression regimen for Hepatocellular Carcinoma (HCC) patients after liver transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MMF and/or steroids | Drug | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
| Tacrolimus | Drug | — | UNRESOLVED |
| Tacrolimus (Tacrolimus elimination) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Tacrolimus-based group
- description
- Tacrolimus-based immunosuppression regimen: Tacrolimus+MMF and/or steroids
- interventionNames
- Drug: Tacrolimus
- Drug: MMF and/or steroids
- type
- EXPERIMENTAL
- label
- Sirolimus-based group
- description
- Sirolimus-based immunosuppression regimen: Tacrolimus (Tacrolimus elimination 30 (± 5) days post LT)+Sirolimus+MMF and/or steroids
- interventionNames
- Drug: Tacrolimus (Tacrolimus elimination)
- Drug: Sirolimus
- Drug: MMF and/or steroids
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Recipients who are 18-65 years of age * Histologically proven HCC before randomization * Recipients who have been initiated on an immunosuppressive regimen that contains tacrolimus, 3-7 days post-transplantation * Allograft is functioning at an acceptable level by the time of randomization as defined by protocol specific laboratory values * Ability and willingness to provide written informed consent and adhere to study regimen Exclusion Criteria: * Patients with non-HCC malignancies within the past 5 years * Patients who are multiple-organ recipients * Patients who are known HIV-positive patients * Patients who have received mTOR inhibitors prior to day 30 after liver transplantation * Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients * Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drug * Patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule
References
Publications (0)
Data not yet available
No reference posted for this study.