Sirolimus-Based Immunosuppression Therapy in OLT for Patients With HCC Exceeding Milan Criteria

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the influence of sirolimus on outcome after OLT for HCC exceeding Milan criteria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Everolimus; Sirolimus

Criteria

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.