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Completed

NCT Number: NCT00328770

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

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

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Key information

Conditions

Liver Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients less than 18 years of age

Treatment and study plan

sirolimus

Drug

Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l

Other names: Rapamune

Primary outcomes

  1. Percentage of Participants Surviving at One and Four Years After Liver Transplant

    Time frame: 1 & 4 years

    Percent of Patients Surviving at One & Four years after Liver Transplant was calculated

  2. Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant

    Time frame: 1 and 4 years

    Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant

Secondary outcomes

  1. Sirolimus Toxicity/Intolerance

    Time frame: 1 year

    Sirolimus toxicity/intolerance requiring discontinuation of sirolimus

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma: Long-Term Outcomes and Side Effects

Important dates

Study start
1996
Primary completion
2006
Study completion
2006
First posted
May 22, 2006
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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