Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

— Impact AFP  

Official title:

Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156582
• Other study ID #: 38RC15.170
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a French multicentric retrospective study on intention-to-treat comparing results of LT for HCC before and after the use of the AFP score. The investigators hypothesis is a better respect of the Biomedicine Agency (the French national transplantation agency) criteria since the general application of this score in March 2013. The aim of this study is to determine if the tumoral characteristics at the time of LT are improved and if it modified the patients'outcome.

Description:

Liver transplantation is a widely accepted treatment for HCC as it would eliminate the tumour and cure the underlying liver disease. But the success of liver transplantation depends on the tumour load; patients with extensive disease have very poor outcomes, whereas most patients with small tumours can be curred. This had to be taken into account in the context of worldwide organ shortage.

That is why in 1996 Mazzaferro et al. have reported Milan criteria limiting access to liver transplantation for patients with a single tumor ≤ 5 cm or ≤ 3 tumors ≤ 3 cm without tumor invasion or metastasis.

However, in France, these criteria were not respected in about 30% of cases, because they were considered too restrictive and unadapted, with good overall results. This led to the possibility of new criteria definition. Because the value of alpha-foeto-protein was known as a good predictor of tumor aggressivity, a new score emerged in 2012, integrating blocking α-fetoprotein thresholds while allowing an increased number and size of tumors. After validation of this score, the Biomedicine Agency decided to use this α-fetoprotein score, to make the selection of patients allowed to be transplanted since March 2013.

In this multicentric retrospective comparative study The investigators first want to assess if this new score based on imaging is also respected at the explant analysis. Our secondary outcomes are to compare the amount of dropped out patients because of this score, the rate of tumoral relapse, the overall survival and the disease free survival.

The investigators aim at collecting the data of 562 patients registered for Liver Transplantation for Hepatocellular Carcinoma between 2011/03/01 and 2014/03/01 in 5 centres: Paul Brousse (Paris), Montpellier, Lille, Lyon and Grenoble.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients registered for liver transplantation because of Hepatocellular carcinoma between 2011/03/01 and 2014/03/01 in 5 french hospital : Paul Brousse (Paris), Montpellier, Lille Lyon and Grenoble

Exclusion Criteria:

• Patients with a MELD score superior to 20 (because this rate give them access to liver transplantation sooner than the other patients).

• Patients of Domino's grafts

• patients with non hepatocellular tumors on the explanted liver

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• Data collecting

Locations

Country	Name	City	State
France	University Hospital, Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Decaens T, Roudot-Thoraval F, Badran H, Wolf P, Durand F, Adam R, Boillot O, Vanlemmens C, Gugenheim J, Dharancy S, Bernard PH, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Hilleret MN, Chazouillères O, Cherqui D, Mallat A, Duvoux C. Impact of tumour differentiation to select patients before liver transplantation for hepatocellular carcinoma. Liver Int. 2011 Jul;31(6):792-801. doi: 10.1111/j.1478-3231.2010.02425.x. Epub 2011 Mar 31. — View Citation

Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Dhumeaux D, Cherqui D, Duvoux C. Impact of pretransplantation transarterial chemoembolization on survival and recurrence after liver transplantation for hepatocellular carcinoma. Liver Transpl. 2005 Jul;11(7):767-775. doi: 10.1002/lt.20418. — View Citation

Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Compagnon P, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouillères O, Cherqui D, Duvoux C. Role of immunosuppression and tumor differentiation in predicting recurrence after liver transplantation for hepatocellular carcinoma: a multicenter study of 412 patients. World J Gastroenterol. 2006 Dec 7;12(45):7319-25. — View Citation

Decaens T, Roudot-Thoraval F, Hadni-Bresson S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Sulpice L, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Cherqui D, Duvoux C. Impact of UCSF criteria according to pre- and post-OLT tumor features: analysis of 479 patients listed for HCC with a short waiting time. Liver Transpl. 2006 Dec;12(12):1761-9. — View Citation

Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouillères O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including a-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants whose tumoral characteristics on the liver explant were under the criteria of the AFP score	For participants undergoing transplantation, the investigators calculated their AFP score at the time of LT, according to the last value of alphafoetoprotein rate, the number and the size of tumors on the explant. They compared the number of patients whose tumoral characteristics on the liver explant were under the criteria of the AFP score in the two arms.	From date of registration for Liver Transplantation until the date of transplantation, assessed up to three years.
Secondary	Rate of patients dropped off list of LT for HCC	Determining if a patient has been excluded by his Transplantation team because of a tumor beyond the Agence de Biomedecine's criteria and comparing the two arms.	From date of registration on the list until the date of exclusion, assessed up to three years.
Secondary	Rate of early tumor recurrence after LT for HCC	Determining in the follow up of patients if they present a liver or extra-hepatic recurrence of HCC at 2 years after LT and comparing the two arms.	Two years after liver transplantation
Secondary	Rate of tumor recurrence after LT for HCC	Determining in the follow up of patients after LT if they present a liver or extra-hepatic recurrence of HCC and comparing the two arms.	From the date of transplantation until the first documented recurrence, assessed through study completion, an average of three years.
Secondary	Overall survival after LT for HCC	Calculating the overall survival according to the last follow up of patients after LT and comparing the two arms.	From the date of transplantation until the date of death or the date of the last consultation, assessed through study completion, an average of three years
Secondary	Progression free survival after LT for HCC	Calculating the progressing free survival according to the time of the eventual relapse after LT and comparing the two arms	From the date of transplantation until the date of first documented recurrence or the date of the last consultation if no recurrence occurs, assessed through study completion, an average of three years.