NCT01374750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started May 2010

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

6 years

First QC Date

April 21, 2011

Last Update Submit

May 30, 2016

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate recurrence-free survival

    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

    3 years

Secondary Outcomes (3)

  • To evaluate the survival rate

    3 years

  • To evaluate the renal function

    3 years

  • To evaluate the safety with sirolimus

    3 years

Study Arms (2)

m-TOR inhibitor free

ACTIVE COMPARATOR

Immunosuppressive drug

Drug: m-TOR inhibitor free

Sirolimus

EXPERIMENTAL

Immunosuppressive drug

Drug: Sirolimus

Interventions

SirolimusDRUG

Sirolimus

Also known as: Rapamune
Sirolimus
m-TOR inhibitor freeDRUG

calcineurin inhibitors

Also known as: Tacrolimus, Cyclosporine
m-TOR inhibitor free

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 yrs and weight ≥ 40 kg.
  • Histologically proven HCC exceeding Milan criteria before randomization, regardless of the prior therapy
  • Signed and dated written informed consent

You may not qualify if:

  • 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.
  • Multiple organ recipients
  • Deceased donor liver transplant
  • Known hypersensitivity to Simulect®, sirolimus, tacrolimus, cyclosporine, or MMF or its derivatives
  • Hyperlipidemia refractory to optimal medical management (cholesterol \>300 mg/dl; Triglycerides \> 350 mg/dl)
  • Evidence of significant local or systemic infection at the time of randomization.
  • Known HIV-positive patients
  • Women of child-bearing potential not willing to take contraception
  • Patients with non-HCC malignancies within the past 5 years, excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin
  • 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)
  • Patients with any evidence of extrahepatic HCC metastasis
  • Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule
  • Use of any investigational drug or treatment up to 4 weeks before enrolling in the study and during the 24-month treatment period.
  • Hepatic artery stenosis or occlusion diagnosed by Doppler
  • Patients with severe renal insufficiency at randomization time point (GFR \< 40mL/min, Proteinuria \> 800mg/24hrs)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

SirolimusTacrolimusCyclosporine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Kwang-woong Lee

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general surgery professor

Study Record Dates

First Submitted

April 21, 2011

First Posted

June 16, 2011

Study Start

May 1, 2010

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

KR(1)