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Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma (CATCH)

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ClinicalTrials.gov Identifier: NCT01676194
Recruitment Status : Unknown
Verified October 2015 by Rennes University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2012
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Other: Intra-arterial administration of DC BeadsR Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Survival [ Time Frame: 3 years ]
    Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma

Secondary Outcome Measures :
  1. Dropout rate [ Time Frame: 3 years ]
    Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)

  2. Post-transplantation survival rate [ Time Frame: 3 years ]
  3. Allograft survival [ Time Frame: 3 years ]
  4. Time to dropout [ Time Frame: 3 years ]
  5. Recurrence rate [ Time Frame: 3 years ]
  6. TACE-induced complications (local and general) [ Time Frame: 3 years ]
  7. Contrast agent - induced complications [ Time Frame: 3 years ]
  8. Doxorubicin-induced complications [ Time Frame: 3 years ]
  9. Efficacy of TACE [ Time Frame: 3 years ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676194

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
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

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01676194     History of Changes
Other Study ID Numbers: 2012~A00269-34
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

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

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