Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma

NCT01676194 | Terminated Phase 3 DMC

• 1 other identifier: 2012~A00269-34
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 7

Brief 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

Hepatocellular Carcinoma

Keywords

Transarterial Chemoembolization; Liver transplantation; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Survival

  Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma

  3 years

Secondary Outcomes (9)

• Dropout rate

  3 years

• Post-transplantation survival rate

  3 years

• Allograft survival

  3 years

• Time to dropout

  3 years

• Recurrence rate

  3 years

Study Arms (2)

Intra-arterial administration of DC BeadsR

EXPERIMENTAL

Intra-arterial administration of DC BeadsR, (1 vial of 100-300 µm) as selectively as possible loaded with doxorubicin (50 mg per procedure) and mixed with an equal volume of contrast medium. The first injection will be performed within 21 days following enlisting and repeated 1-2 times until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response

Other: Intra-arterial administration of DC BeadsR

Control

NO INTERVENTION

Usual care

Interventions

Intra-arterial administration of DC BeadsR OTHER

Intra-arterial administration of DC BeadsR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \>18 years
• With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria
• Without general contraindication to LT
• Written informed consent.

You may not qualify if:

• Patients that already had TACE
• Or other local treatment for HCC
• Or neoadjuvant systemic chemotherapy
• Or planned living donor
• Or non arterialized lesion(s)
• Or Contraindication to DC-BeadsR
• Or allergy to contrast agents
• Or contraindication to Doxorubicin.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (7)

Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris

Créteil, 94010, France

Location

Hôpital Michalon, CHU de Grenoble

Grenoble, 38000, France

Location

Hôpital Claude Huriez, CHU de Lille

Lille, 59000, France

Location

Hôpital de la Croix Rousse, HCL, Lyon

Lyon, 69000, France

Location

Hôpital Saint-Antoine / APHP

Paris, 75000, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Trousseau, CHU de Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe COMPAGNON, MD

  Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est

  PRINCIPAL INVESTIGATOR

• Karim BOUDJEMA, MD PhD

  Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1

  PRINCIPAL INVESTIGATOR

• Bruno Laviolle, MD, PhD

  Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: May 28, 2014
• Study Completion: February 16, 2016
• Last Updated: April 12, 2019

Record last verified: 2018-09

Locations

FR (7)