Efficacy of Sirolimus In Liver Transplantation for Hepatocellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the anti-tumor effect of sirolimus-based immunosuppressive regimen in patients following living donor liver transplantation for hepatocellular carcinoma exceeding Milan criteria with respect to recurrence-free survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria :

1. Age ≥ 18 yrs and weight ≥ 40 kg.

2. Histologically proven HCC exceeding Milan criteria before randomization, regardless of the prior therapy

3. Signed and dated written informed consent

4. Lack of relevant exclusion criteria

5. Women who were of childbearing potential must have had a negative qualitative serum pregnancy test before Investigational agent administration and must have agreed to use a medically acceptable method of contraception during treatment period of the study.

Exclusion Criteria :

1. Multiple organ recipients

2. Deceased donor liver transplant

3. Known hypersensitivity to Simulect®, sirolimus, tacrolimus, cyclosporine, or MMF or its derivatives

4. Hyperlipidemia refractory to optimal medical management (cholesterol >300 mg/dl; Triglycerides > 350 mg/dl)

5. Evidence of significant local or systemic infection at the time of randomization.

6. Known HIV-positive patients

7. Women of child-bearing potential not willing to take contraception

8. Patients with non-HCC malignancies within the past 5 years, excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin

9. Patients with HCC involvement of a major branch(portal vein, hepatic vein, etc.) of any hepatic blood vessel on pathological evaluation c.f. Major branch is defined as the first or the second order branch (e.g. In case of the portal vein, right and left portal vein, right anterior and posterior portal vein, and left medial and lateral portal vein)

10. Patients with any evidence of extrahepatic HCC metastasis

11. Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule

12. Use of any investigational drug or treatment up to 4 weeks before enrolling in the study and during the 24-month treatment period.

13. Hepatic artery stenosis or occlusion diagnosed by Doppler

14. Patients with severe renal insufficiency at randomization time point (GFR < 40mL/min, Proteinuria > 800mg/24hrs)

15. Patients with severe leucopenia and/or thrombocytopenia refractory to medical treatment (ANC < 500/ul,platelet < 30K/ul)