Liver Carcinoma
Conditions
Keywords
liver transplant, hepatocellular carcinoma, sirolimus
Brief summary
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.
Detailed description
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.
Interventions
DRUGSirolimus
Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
Sponsors
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant
Exclusion criteria
* Patients less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Surviving at One and Four Years After Liver Transplant | 1 & 4 years | Percent of Patients Surviving at One & Four years after Liver Transplant was calculated |
| Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant | 1 and 4 years | Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sirolimus Toxicity/Intolerance | 1 year | Sirolimus toxicity/intolerance requiring discontinuation of sirolimus |
Countries
Canada
Participant flow
Recruitment details
All adults receiving a liver transplant between December 1996 and March 2006 who had hepatocellular carcinoma and were treated with sirolimus as part of their immunosuppression after their transplant were included in this trial.
Participants by arm
| Arm | Count |
|---|---|
| All Study Patients All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | All Study Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age Continuous | 54.6 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment Canada | 70 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 70 |
| serious Total, serious adverse events | 7 / 70 |
Outcome results
Primary
Percentage of Participants Surviving at One and Four Years After Liver Transplant
Percent of Patients Surviving at One & Four years after Liver Transplant was calculated
Time frame: 1 & 4 years
Population: Percentage of patients surviving to 1 and 4 years after liver transplant was calculated for all patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Survival | Percentage of Participants Surviving at One and Four Years After Liver Transplant | 4 year patient survival | 77 percentage of participants |
| Patient Survival | Percentage of Participants Surviving at One and Four Years After Liver Transplant | 1 year patient survival | 85 percentage of participants |
Primary
Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant
Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant
Time frame: 1 and 4 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Survival | Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant | 1 year tumor-free survival | 84 percentage of participants |
| Patient Survival | Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant | 4 year tumor-free survival | 74 percentage of participants |
Secondary
Sirolimus Toxicity/Intolerance
Sirolimus toxicity/intolerance requiring discontinuation of sirolimus
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Survival | Sirolimus Toxicity/Intolerance | 13 participants |