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Expansion of Conventional Criteria for Liver Transplantation in Hepatocellular Carcinoma Through Downstaging

NCT01387503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2021-10-11

No results posted yet for this study

Summary

This clinical trial is aimed at extending the chance of liver transplantation, through downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding conventional Milan Criteria.

Those patients that will achieve a sustained tumor response after downstaging will be randomized either to undergo liver transplantation or to proceed with conventional non-transplant treatments.

The aim of the study is to demonstrate unequivocally that liver transplantation may provide a survival benefit, with an acceptable survival rate of at least 60% at 5 years, to patients that demonstrate a radiological and sustained tumor response after downstaging. Noteworthy is that response is chosen rather than stage migration as endpoint of downstaging.

Conditions

  • Carcinoma, Hepatocellular
  • Cirrhosis

Interventions

PROCEDURE

Liver transplantation

Once randomized to Group 1, patients will be enlisted for liver transplantation at the recruiting Center. Prioritization is encouraged as a waiting time of more than 8 months could cause patients' drop-out from the study

Sponsors & Collaborators

  • AISF (Associazione Italiana per lo Studio del Fegato)

    collaborator UNKNOWN

  • CNT (Centro Nazionale Trapianti)

    collaborator UNKNOWN

  • NITp (Nord Italia Transplant project)

    collaborator UNKNOWN

  • OCST (Organizzazione Centro Sud Trapianti)

    collaborator UNKNOWN

  • Associazione Italiana per la Ricerca sul Cancro

    collaborator OTHER

  • Ministero della Salute, Italy

    collaborator OTHER

  • Basilicata Region

    collaborator UNKNOWN

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Vincenzo Mazzaferro, MD · Istituto Nazionale Tumori, Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-03-31
Completion
2019-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01387503 on ClinicalTrials.gov