Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment intra-arterial administration of dc beadsr
Phase phase 3
Sponsor Rennes University Hospital
Start date August 2012
End date August 2017
Trial size 140 participants
Trial identifier NCT01676194, 2012~A00269-34

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
intra-arterial administration of dc beadsr
(No Intervention)
Usual care

Primary Outcomes

Measure
Survival
time frame: 3 years

Secondary Outcomes

Measure
Dropout rate
time frame: 3 years
Post-transplantation survival rate
time frame: 3 years
Allograft survival
time frame: 3 years
Time to dropout
time frame: 3 years
Recurrence rate
time frame: 3 years
TACE-induced complications (local and general)
time frame: 3 years
Contrast agent - induced complications
time frame: 3 years
Doxorubicin-induced complications
time frame: 3 years
Efficacy of TACE
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients >18 years - With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria - Without general contraindication to LT - Written informed consent. Exclusion Criteria: - 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.

Additional Information

Official title Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
Principal investigator Philippe COMPAGNON, MD
Description - Multicentre, prospective, randomized, 2 parallel group study - Preoperative evaluation of hepatocellular carcinoma in recipients: Tumor diagnosis will be mainly based upon EASL guidelines. HCCs will be classified according to UCSF criteria (size, number of nodules). Clinical and biological status will be updated every 3 month. - Pre-transplant treatment: TACE group: An emulsion of Lipiodol and a cytotoxic drug (50mg/m2 of doxorubicin) will be injected as selectively as possible. Then, an embolic agent will be used to assure stop of flow. The first injection will be performed within 10 days following enlisting and repeated every 8 weeks 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. Clinical/biological follow-up will be done once a month. Control group (no treatment until LT): clinical/biological follow-up and CT-scan every 3 month. This prospective, multicentric, and randomized study may allow investigators to show that TACE with DC-BeadsR can significantly increase intention to treat survival of patients transplanted for HCC. We also expect that this result will be associated with less recurrence of the cancer after transplantation. Obviously, we expect that the beneficial effect of TACE will be associated with a acceptable rate of complication related to the procedure. - Pathologic examination: In all patients in whom LT will be performed, the diagnosis of hepatocellular carcinoma will be confirmed by a histological examination of the explanted liver. - Dropout criteria: Patients with progression but still meeting the transplant criteria will be maintained in their respective group. Patients with progression over the transplant criteria will be excluded from the waiting list and censored.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Rennes University Hospital.