Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

— EFAPRE  

Official title:

Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198704
• Other study ID #: AOM07237
• Status: Completed
• Start date: January 2009
• Est. completion date: January 2020

Study information

• Verified date: November 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 reassess criteria for liver transplantation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: January 2020
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Evidence of Liver Transplantation
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Recurrence

Intervention

Other:
• search of factors predicting tumor recurrence
Morphological, chronological, anatomy-pathological and molecular search

Locations

Country	Name	City	State
France	Clinique Universitaire d'Hépato-gastroentérologie	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive factors of HCC recurrence		at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)
Secondary	Predictive factors of tumor-free recurrence		at 3 years
Secondary	Predictive factors of overall survival at 5 years		at 5 years
Secondary	Predictive factors of drop-out		during the waiting time
Secondary	Radio-pathological correlation		end of the study
Secondary	Correlation of HCC differentiation between liver biopsy and explant liver		at 32 month