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NCT02995096 Clinical Trial

Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

Liver Transplantation Clinical Trial

Official title:
The Effect of Tumor Characteristics, Pre-transplant Treatments and Immunosuppression on Survival After Liver Transplantation for Hepatocellular Carcinoma - a European Registry Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02995096
Other study ID # There is no unique protocol ID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date March 2019

Study information
Verified date March 2019
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.

Recruitment information / eligibility
Status Completed
Enrollment 23124
Est. completion date March 2019
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Hepatocellular carcinoma within transplantation criteria

Exclusion Criteria:

- Disseminated disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Pre-treatment
Non-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization)
Drug:
• Sirolimus based immunosuppression
Immunosuppression regimens containing Sirolimus

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival up to 10 year survival
Secondary Hepatocellular carcinoma specific survival 5 year and 10 year survival
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