Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma (CATCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01676194
First received: August 28, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Other: Intra-arterial administration of DC BeadsR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma


Secondary Outcome Measures:
  • Dropout rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)

  • Post-transplantation survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Allograft survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to dropout [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • TACE-induced complications (local and general) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Contrast agent - induced complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Doxorubicin-induced complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Efficacy of TACE [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 140
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-arterial administration of DC BeadsR
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
No Intervention: Control
Usual care

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676194

Locations
France
Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris
Créteil, France, 94010
Hôpital Michalon, CHU de Grenoble
Grenoble, France, 38000
Hôpital Claude Huriez, CHU de Lille
Lille, France, 59000
Hôpital de la Croix Rousse, HCL, Lyon
Lyon, France, 69000
Hôpital Saint-Antoine / APHP
Paris, France, 75000
Hôpital Pontchaillou
Rennes, France, 35033
Hôpital Trousseau, CHU de Tours
Tours, France, 37000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: 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
Study Chair: Bruno Laviolle, MD, PhD Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01676194     History of Changes
Other Study ID Numbers: 2012~A00269-34
Study First Received: August 28, 2012
Last Updated: August 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Transarterial Chemoembolization
Liver transplantation
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014