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NCT Number: NCT03156582

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Grenoble Alpes

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collecting

Other

Primary outcomes

  1. Number of participants whose tumoral characteristics on the liver explant were under the criteria of the AFP score

    Time frame: From date of registration for Liver Transplantation until the date of transplantation, assessed up to three years.

    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.

Secondary outcomes

  1. Rate of patients dropped off list of LT for HCC

    Time frame: From date of registration on the list until the date of exclusion, assessed up to three years.

    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.

  2. Rate of early tumor recurrence after LT for HCC

    Time frame: Two years after liver transplantation

    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.

  3. Rate of tumor recurrence after LT for HCC

    Time frame: From the date of transplantation until the first documented recurrence, assessed through study completion, an average of three years.

    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.

  4. Overall survival after LT for HCC

    Time frame: 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

    Calculating the overall survival according to the last follow up of patients after LT and comparing the two arms.

  5. Progression free survival after LT for HCC

    Time frame: 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.

    Calculating the progressing free survival according to the time of the eventual relapse after LT and comparing the two arms

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: Impact AFP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 17, 2017
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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