<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01676194</url>
  </required_header>
  <id_info>
    <org_study_id>2012~A00269-34</org_study_id>
    <nct_id>NCT01676194</nct_id>
  </id_info>
  <brief_title>Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma</brief_title>
  <acronym>CATCH</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hope to treat more patients with hepatocellular carcinoma successfully is however&#xD;
      tempered by the shortage of donors leading to an increasing waiting time for liver&#xD;
      transplantation (LT). Intention-to-treat analysis have showed that the reported excellent&#xD;
      long-term outcome is curtailed and significantly hampered by the growing incidence of&#xD;
      patients who must be removed from the waiting list because of tumor progression. A way to&#xD;
      face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic&#xD;
      options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most&#xD;
      common modality used. While there are many studies concerning TACE in this setting, none are&#xD;
      controlled studies and thus there is no firm evidence concerning its efficacy in reducing&#xD;
      drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial&#xD;
      complications…) while waiting for LT. Most of the available data have been based upon&#xD;
      analysis of patients who received a transplant and have not included patients who were&#xD;
      eligible for LT but died, or showed progression, before it could be performed. Therefore,&#xD;
      studies conducted on an intention-to-treat basis are needed to clarify the benefit and the&#xD;
      risks of TACE prior to LT in patients with hepatocellular carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Multicentre, prospective, randomized, 2 parallel group study&#xD;
&#xD;
        -  Preoperative evaluation of hepatocellular carcinoma in recipients: Tumor diagnosis will&#xD;
           be mainly based upon EASL guidelines. HCCs will be classified according to UCSF criteria&#xD;
           (size, number of nodules). Clinical and biological status will be updated every 3 month.&#xD;
&#xD;
        -  Pre-transplant treatment:&#xD;
&#xD;
      TACE group: An emulsion of Lipiodol and a cytotoxic drug (50mg/m2 of doxorubicin) will be&#xD;
      injected as selectively as possible. Then, an embolic agent will be used to assure stop of&#xD;
      flow. The first injection will be performed within 10 days following enlisting and repeated&#xD;
      every 8 weeks until LT (only if hypervascularized vital tumor tissue is again visible on CT&#xD;
      Scan and if liver function remains within Child A stage) or until complete response.&#xD;
      Clinical/biological follow-up will be done once a month.&#xD;
&#xD;
      Control group (no treatment until LT): clinical/biological follow-up and CT-scan every 3&#xD;
      month.&#xD;
&#xD;
      This prospective, multicentric, and randomized study may allow investigators to show that&#xD;
      TACE with DC-BeadsR can significantly increase intention to treat survival of patients&#xD;
      transplanted for HCC. We also expect that this result will be associated with less recurrence&#xD;
      of the cancer after transplantation.&#xD;
&#xD;
      Obviously, we expect that the beneficial effect of TACE will be associated with a acceptable&#xD;
      rate of complication related to the procedure.&#xD;
&#xD;
        -  Pathologic examination: In all patients in whom LT will be performed, the diagnosis of&#xD;
           hepatocellular carcinoma will be confirmed by a histological examination of the&#xD;
           explanted liver.&#xD;
&#xD;
        -  Dropout criteria: Patients with progression but still meeting the transplant criteria&#xD;
           will be maintained in their respective group. Patients with progression over the&#xD;
           transplant criteria will be excluded from the waiting list and censored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient recruitment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 16, 2016</completion_date>
  <primary_completion_date type="Actual">May 28, 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>3 years</time_frame>
    <description>Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dropout rate</measure>
    <time_frame>3 years</time_frame>
    <description>Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-transplantation survival rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allograft survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to dropout</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TACE-induced complications (local and general)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast agent - induced complications</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doxorubicin-induced complications</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of TACE</measure>
    <time_frame>3 years</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Intra-arterial administration of DC BeadsR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intra-arterial administration of DC BeadsR</intervention_name>
    <arm_group_label>Intra-arterial administration of DC BeadsR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients &gt;18 years&#xD;
&#xD;
          -  With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria&#xD;
&#xD;
          -  Without general contraindication to LT&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that already had TACE&#xD;
&#xD;
          -  Or other local treatment for HCC&#xD;
&#xD;
          -  Or neoadjuvant systemic chemotherapy&#xD;
&#xD;
          -  Or planned living donor&#xD;
&#xD;
          -  Or non arterialized lesion(s)&#xD;
&#xD;
          -  Or Contraindication to DC-BeadsR&#xD;
&#xD;
          -  Or allergy to contrast agents&#xD;
&#xD;
          -  Or contraindication to Doxorubicin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe COMPAGNON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karim BOUDJEMA, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Laviolle, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Michalon, CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Claude Huriez, CHU de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Rousse, HCL, Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine / APHP</name>
      <address>
        <city>Paris</city>
        <zip>75000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Trousseau, CHU de Tours</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transarterial Chemoembolization</keyword>
  <keyword>Liver transplantation</keyword>
  <keyword>Hepatocellular carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01676194
org study id: 2012~A00269-34
nct id: NCT01676194
lead sponsor: 
has dmc: Yes
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.
-  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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 3 years
description: Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
measure: Dropout rate
time frame: 3 years
description: Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)
measure: Post-transplantation survival rate
time frame: 3 years
measure: Allograft survival
time frame: 3 years
measure: Time to dropout
time frame: 3 years
measure: Recurrence rate
time frame: 3 years
measure: TACE-induced complications (local and general)
time frame: 3 years
measure: Contrast agent - induced complications
time frame: 3 years
measure: Doxorubicin-induced complications
time frame: 3 years
measure: Efficacy of TACE
time frame: 3 years
description: 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)
arm group label: Intra-arterial administration of DC BeadsR
arm group type: Experimental
description: 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
arm group label: Control
arm group type: No Intervention
description: Usual care
intervention type: Other
intervention name: Intra-arterial administration of DC BeadsR
arm group label: Intra-arterial administration of DC BeadsR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe COMPAGNON, MD
role: Principal Investigator
affiliation: Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est
last name: Karim BOUDJEMA, MD PhD
role: Principal Investigator
affiliation: Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1
last name: Bruno Laviolle, MD, PhD
role: Study Chair
affiliation: Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular