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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01374750
• Date of registration: 21/04/2011
• Primary sponsor: Seoul National University Hospital
• Public title: Efficacy of Sirolimus In Liver Transplantation for Hepatocellular Carcinoma (HCC) Sirolimus
• Scientific title: A Randomized Phase ?, Trial With Sirolimus-containing Versus mTOR-inhibitor Free Immunosuppression in Patients Undergoing Living Donor Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria
• Date of first enrolment: May 2010
• Target sample size: 86
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01374750
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Yu-kyung Jee

• Name: Yu-kyung Jee

• Name: Kwang-woong Lee
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma

Intervention(s)

Drug: m-TOR inhibitor free

Drug: Sirolimus

Primary Outcome(s)

To evaluate recurrence-free survival [Time Frame: 3 years]

Secondary Outcome(s)

To evaluate the renal function [Time Frame: 3 years]

To evaluate the safety with sirolimus [Time Frame: 3 years]

To evaluate the survival rate [Time Frame: 3 years]

Secondary ID(s)

H-1004-052-316

KWLee1004-052-316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors