Clinical trial · Interventional
Sirolimus-Based Immunosuppression Therapy in OLT for Patients With HCC Exceeding Milan Criteria
A Prospective Randomised, Open-Labeled Study Comparing Sirolimus Versus FK506 In OLT for Patients With HCC Exceeding Milan Criteria
NCT00554125CI-TRIAL-00000956unknownPhase 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)
The purpose of this study is to evaluate the influence of sirolimus on outcome after OLT for HCC exceeding Milan criteria.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- 2, III ,intervention
- interventionNames
- Drug: sirolimus
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 3-,5-year
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- 3-,5-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The major organ (liver,heart, lung and kidney) function after OLT was normal. * Pathologically proved HCC before randomisation . * Tumor exceeding the Milan criteria (one nodule ≤5 cm or 2-3 nodules all \<3 cm, without macroscopic vascular invasion and extrahepatic spreading). * Signed, written informed consent. Exclusion Criteria: * Extrahepatic metastasis, nodal involvement, perioperative deaths (within 30 days after operation), and tumor thrombi in the proximal main trunk of the portal vein and / or vena cava * History of cardiac disease. * Active clinically serious infection (\>grade 2 Nation Cancer Institute NCI-CTCAE version 3.0). * Known history of human immunodeficiency virus (HIV) infection. * Any condition that is unstable or which could jeopardize the safety of the patient and his / her compliance in the study. * Pregnant or breast-feeding patients.
References
Publications (1)
- DERIVEDTreiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247. PMID 19192962