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


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Both
Liver Carcinoma

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Trial Information

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


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.


Inclusion Criteria:



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

Exclusion criteria:

- Patients less than 18 years of age

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

1 & 4 years

Safety Issue:

No

Principal Investigator

Norman M Kneteman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta

Authority:

Canada: Health Canada

Study ID:

#4279

NCT ID:

NCT00328770

Start Date:

December 1996

Completion Date:

March 2006

Related Keywords:

  • Liver Carcinoma
  • liver transplant
  • hepatocellular carcinoma
  • sirolimus
  • Carcinoma
  • Carcinoma, Hepatocellular

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