De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

University of Alberta

Status and phase: Completed; Phase 3; Phase 2

Conditions: Liver Carcinoma

Treatments: Drug: Sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00328770

#4279

Details and patient eligibility

About

This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

Full description

A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant

Exclusion criteria

• Patients less than 18 years of age

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

Sirolimus based immunosuppression

Experimental group

Description:

Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l

Treatment:

Drug: Sirolimus