This trial is active, not recruiting.

Conditions hepatocellular carcinoma, liver cirrhosis, evidence of liver transplantation
Treatment search of factors predicting tumor recurrence
Sponsor Assistance Publique - Hôpitaux de Paris
Start date January 2009
End date March 2017
Trial size 372 participants
Trial identifier NCT01198704, AOM07237


Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.

The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassessed criteria for liver transplantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients notified on the national waiting list for hepatic transplant
search of factors predicting tumor recurrence search of factors predicting tumor recurrence
Morphological, chronological, anatomy-pathological and molecular search

Primary Outcomes

Predictive factors of HCC recurrence
time frame: at 1 year after Liver transplantation for HCC

Secondary Outcomes

Predictive factors of tumor-free recurrence
time frame: at 3 years
Predictive factors of overall survival at 5 years
time frame: at 5 years
Predictive factors of drop-out
time frame: during the waiting time
Radio-pathological correlation
time frame: end of the study
Correlation of HCC differentiation between liver biopsy and explant liver
time frame: at 32 month

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Liver cirrhosis - Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy - Listing for Liver transplantation for HCC fulfilling or not Milan criteria - No extra-hepatic spread - No vascular involvement Exclusion Criteria: - Salvage transplantation - Transplantation contra-indication - Evaluation for Liver transplantation older than 1 month - Incidental HCC

Additional Information

Official title Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma
Principal investigator Thomas Decaens, MD, PhD
Description In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing. The investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological). Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.