Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— CATCH  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01676194
• Other study ID #: 2012~A00269-34
• Status: Terminated
• Phase: Phase 3
• Start date: August 2012
• Est. completion date: February 16, 2016

Study information

• Verified date: September 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 16, 2016
• Est. primary completion date: May 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• Intra-arterial administration of DC BeadsR

Locations

Country	Name	City	State
France	Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris	Créteil
France	Hôpital Michalon, CHU de Grenoble	Grenoble
France	Hôpital Claude Huriez, CHU de Lille	Lille
France	Hôpital de la Croix Rousse, HCL, Lyon	Lyon
France	Hôpital Saint-Antoine / APHP	Paris
France	Hôpital Pontchaillou	Rennes
France	Hôpital Trousseau, CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dropout rate	Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)	3 years
Secondary	Post-transplantation survival rate		3 years
Secondary	Allograft survival		3 years
Secondary	Time to dropout		3 years
Secondary	Recurrence rate		3 years
Secondary	TACE-induced complications (local and general)		3 years
Secondary	Contrast agent - induced complications		3 years
Secondary	Doxorubicin-induced complications		3 years
Secondary	Efficacy of TACE	Efficacy of TACE (morphological response to TACE: captation rate of Lipiodol and morphological response (RECIST guidelines), as well as histological criteria: percentage of necrosis on pathological examination)	3 years