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This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus based immunosuppression | Experimental | Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 & 4 years |
| 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 | 1 and 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sirolimus Toxicity/Intolerance | Sirolimus toxicity/intolerance requiring discontinuation of sirolimus | 1 year |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman M Kneteman, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19192962 | Derived | Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Patients | All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Patients | All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Percentage of patients surviving to 1 and 4 years after liver transplant was calculated for all patients | Posted | Number | percentage of participants | 1 & 4 years |
|
|
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Only Adverse Events related to toxicity were collected/reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Patients | All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematological toxicity | Blood and lymphatic system disorders | Systematic Assessment | Anemia defined as hemoglobin under 8 g/dL for at least one week or requiring treatment. Leucopenia defined as leukocyte counts under 3 x 10-9/L for at least 5 days or requiring granulocyte colony-stimulating factor therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mouth ulcers | Gastrointestinal disorders | Systematic Assessment | Oral ulcers necessitating patients being discontinued from sirolimus therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Norman Kneteman | Liver Transplant Program, University of Alberta Hospitals | 780-407-6168 | norm.kneteman@albertahealthservices.ca |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 | Posted | Number | percentage of participants | 1 and 4 years |
|
|
|
| Secondary | Sirolimus Toxicity/Intolerance | Sirolimus toxicity/intolerance requiring discontinuation of sirolimus | Posted | Number | participants | 1 year |
|
|
|
| 7 |
| 70 |
| 6 |
| 70 |
|
| Delayed wound healing | Skin and subcutaneous tissue disorders | Systematic Assessment | Delayed wound healing defined as a wound still requiring nursing therapy one month after surgery. |
|
|
| Dyslipidemia | Metabolism and nutrition disorders | Systematic Assessment | Dyslipidemia necessitating patient have sirolimus discontinued. |
|
| Other unspecified reasons for discontinuation of sirolimus | General disorders | Systematic Assessment | Reasons patients were discontinued from sirolimus therapy were not specified by the physicians who took the patients off the medication. |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |