Clinical trial · Observational
AFP Model and Liver Transplantation.
Evaluation of the AFP Model in Predicting Recurrence of Hepatocellular Carcinoma After Liver Transplantation in Patients Without Microvascular Invasion.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background \& Aim: Presence of microvascular invasion (mvi) in the explanted liver defines a higher risk of recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT). The aim of this study is to evaluate pre LT selection models of HCC recurrence specifically in patients without mvi in the explanted liver. Methods: Three multicenter cohorts are going to be included: a Latin American, a French and an Italian cohort of consecutive adult patients with HCC a first LT performed during two different periods: 2005-2011 and 2012-2016. AFP model is going to be compared against Milan and San Francisco criteria according to each models accuracy and prediction of HCC recurrence among patients without microvascular invasion in the explanted liver considering these candidates as "Low-risk patients". Multivariate Cox regression analysis, with hazard ratios (HR) and 95% confidence intervals (CI) for 5-year recurrence is going to be done with Competing Risk Regression analysis and corresponding Subhazard Ratios (SHR).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Transplant Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Latin American multicenter Cohort
- description
- Transplanted patients with HCC in LATAM from 2005-2011
- interventionNames
- Procedure: Liver transplantation
- label
- French mutlicenter Cohort
- description
- Transplanted patients with HCC in France from 2003-2005
- interventionNames
- Procedure: Liver transplantation
- label
- Italian multicenter Cohort
- description
- Transplanted patients with HCC in Italy from 2005-2011
- interventionNames
- Procedure: Liver transplantation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
Show eligibility criteria text
Inclusion Criteria: . Criteria for inclusion required patients to be adult cirrhotic or non-cirrhotic recipients with confirmed HCC in the explanted liver. Exclusion Criteria: * other tumors than HCC are confirmed in the explanted liver, * there are missing relevant information; * extrahepatic or macrovascular tumor invasion were observed during pre transplant evaluation or in the explanted liver * incidental HCC, * had a previous liver transplant
References
Publications (4)
- DERIVEDCostentin C, Pinero F, Degroote H, Notarpaolo A, Boin IF, Boudjema K, Baccaro C, Podesta LG, Bachellier P, Ettorre GM, Poniachik J, Muscari F, Dibenedetto F, Duque SH, Salame E, Cillo U, Marciano S, Vanlemmens C, Fagiuoli S, Burra P, Van Vlierberghe H, Cherqui D, Lai Q, Silva M, Rubinstein F, Duvoux C; French-Italian-Belgium and Latin American collaborative group for HCC and liver transplantation. R3-AFP score is a new composite tool to refine prediction of hepatocellular carcinoma recurrence after liver transplantation. JHEP Rep. 2022 Feb 2;4(5):100445. doi: 10.1016/j.jhepr.2022.100445. eCollection 2022 May. PMID 35360522
- DERIVEDDegroote H, Pinero F, Costentin C, Notarpaolo A, Boin IF, Boudjema K, Baccaro C, Chagas AL, Bachellier P, Ettorre GM, Poniachik J, Muscari F, Di Benedetto F, Duque SH, Salame E, Cillo U, Gadano A, Vanlemmens C, Fagiuoli S, Rubinstein F, Burra P, Cherqui D, Silva M, Van Vlierberghe H, Duvoux C; French-Italian-Belgium and Latin American collaborative group for HCC and liver transplantation. International study on the outcome of locoregional therapy for liver transplant in hepatocellular carcinoma beyond Milan criteria. JHEP Rep. 2021 Jul 13;3(5):100331. doi: 10.1016/j.jhepr.2021.100331. eCollection 2021 Oct. PMID 34485882
- DERIVEDMaccali C, Chagas AL, Boin I, Quinonez E, Marciano S, Vilatoba M, Varon A, Anders M, Hoyos Duque S, Lima AS, Menendez J, Padilla-Machaca M, Poniachik J, Zapata R, Maraschio M, Chong Menendez R, Munoz L, Arufe D, Figueroa R, Soza A, Fauda M, Perales SR, Vergara Sandoval R, Bermudez C, Beltran O, Arenas Hoyos I, McCormack L, Mattera FJ, Gadano A, Parente Garcia JH, Tani CM, Augusto Carneiro D'Albuquerque L, Carrilho FJ, Silva M, Pinero F. Recurrence of hepatocellular carcinoma after liver transplantation: Prognostic and predictive factors of survival in a Latin American cohort. Liver Int. 2021 Apr;41(4):851-862. doi: 10.1111/liv.14736. Epub 2020 Dec 2. PMID 33217193
- DERIVEDPinero F, Anders M, Boin IF, Chagas A, Quinonez E, Marciano S, Vilatoba M, Santos L, Hoyos Duque S, Lima AS, Menendez J, Padilla M, Poniachik J, Zapata R, Soza A, Maraschio M, Chong Menendez R, Munoz L, Arufe D, Figueroa R, de Ataide EC, Maccali C, Vergara Sandoval R, Bermudez C, Podesta LG, McCormack L, Varon A, Gadano A, Mattera J, Villamil F, Rubinstein F, Carrilho F, Silva M. Liver transplantation for hepatocellular carcinoma: impact of expansion criteria in a multicenter cohort study from a high waitlist mortality region. Transpl Int. 2021 Jan;34(1):97-109. doi: 10.1111/tri.13767.