MedTrace Logo

Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma

NCT01676194 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-04-12

No results posted yet for this study

Summary

The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression. A way to face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used. While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT. Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed. Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with hepatocellular carcinoma.

Conditions

Interventions

OTHER

Intra-arterial administration of DC BeadsR

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Philippe COMPAGNON, MD · Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est

  • Karim BOUDJEMA, MD PhD · Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1

  • Bruno Laviolle, MD, PhD · Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-28
Completion
2016-02-16

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01676194 on ClinicalTrials.gov