Trial Outcomes & Findings for De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma (NCT NCT00328770)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

70 participants

Primary outcome timeframe

1 & 4 years

Results posted on

2013-06-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	All Study Patients All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
Overall Study STARTED	70
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Patients n=70 Participants All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	54.6 years STANDARD_DEVIATION 7.3 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	58 Participants n=93 Participants
Region of Enrollment Canada	70 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 & 4 years

Population: Percentage of patients surviving to 1 and 4 years after liver transplant was calculated for all patients

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

Outcome measures

Outcome measures
Measure	Patient Survival n=70 Participants 1 and 4 year patient survival
Percentage of Participants Surviving at One and Four Years After Liver Transplant 1 year patient survival	85 percentage of participants
Percentage of Participants Surviving at One and Four Years After Liver Transplant 4 year patient survival	77 percentage of participants

PRIMARY outcome

Timeframe: 1 and 4 years

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

Outcome measures

Outcome measures
Measure	Patient Survival n=70 Participants 1 and 4 year 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
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 outcome

Timeframe: 1 year

Sirolimus toxicity/intolerance requiring discontinuation of sirolimus

Outcome measures

Outcome measures
Measure	Patient Survival n=70 Participants 1 and 4 year patient survival
Sirolimus Toxicity/Intolerance	13 participants

Adverse Events

All Study Patients

Serious events: 7 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Study Patients n=70 participants at risk All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
Blood and lymphatic system disorders Hematological toxicity	5.7% 4/70 • Number of events 4 Only Adverse Events related to toxicity were collected/reported.
Skin and subcutaneous tissue disorders Delayed wound healing	4.3% 3/70 • Number of events 3 Only Adverse Events related to toxicity were collected/reported.

Other adverse events

Other adverse events
Measure	All Study Patients n=70 participants at risk All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
Gastrointestinal disorders Mouth ulcers	2.9% 2/70 • Number of events 2 Only Adverse Events related to toxicity were collected/reported.
Metabolism and nutrition disorders Dyslipidemia	1.4% 1/70 • Number of events 1 Only Adverse Events related to toxicity were collected/reported.
General disorders Other unspecified reasons for discontinuation of sirolimus	4.3% 3/70 • Number of events 3 Only Adverse Events related to toxicity were collected/reported.

Additional Information

Dr. Norman Kneteman

Liver Transplant Program, University of Alberta Hospitals

Phone: 780-407-6168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place