<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/NCT02202564</url>
  </required_header>
  <id_info>
    <org_study_id>LT-02</org_study_id>
    <nct_id>NCT02202564</nct_id>
  </id_info>
  <brief_title>Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing YouAn Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <brief_summary>
    <textblock>
      HCC patients with tumors &gt;5 cm in diameter, regardless of involvement in the intrahepatic and&#xD;
      extrahepatic portal branches participated in the study. Patients were randomized allocated in&#xD;
      liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received&#xD;
      orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered&#xD;
      to patients twice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>Phase 2</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>Overall survival rate</measure>
    <time_frame>up to 3-year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence-free survival rate</measure>
    <time_frame>up to 3-year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Liver Cancer</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>LT+ADV-TK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Orthotopic liver transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LT</intervention_name>
    <description>Orthotopic LT</description>
    <arm_group_label>LT</arm_group_label>
    <arm_group_label>LT+ADV-TK</arm_group_label>
    <other_name>liver transplantation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADV-TK</intervention_name>
    <arm_group_label>LT+ADV-TK</arm_group_label>
    <other_name>adenovirus-thymidine kinase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ganciclovir</intervention_name>
    <arm_group_label>LT+ADV-TK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18～70 years of age (Male and Female).&#xD;
&#xD;
          -  Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver&#xD;
             transplantation&#xD;
&#xD;
          -  Patients who had unresectable HCC &gt;5 cm and no metastasis in lungs and bones were&#xD;
             eligible to participate in this study. Tumor involvement in the intrahepatic and&#xD;
             extrahepatic portal branches was not considered to be an exclusion criterion.&#xD;
&#xD;
          -  No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological&#xD;
             treatment within 4 weeks.&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastasis in lungs and bones&#xD;
&#xD;
          -  Invasion in main vescular.&#xD;
&#xD;
          -  Contraindications of liver transplantation&#xD;
&#xD;
          -  Contraindications of operation of other organ system&#xD;
&#xD;
          -  Hypersensitivity to adenovirus, GCV or similar drugs&#xD;
&#xD;
          -  Accept clinical trials of other drugs&#xD;
&#xD;
          -  Immunological deficit&#xD;
&#xD;
          -  Active pregnancy&#xD;
&#xD;
          -  Unable or unwilling to sign informed consents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ding Ma, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Ding Ma</investigator_full_name>
    <investigator_title>Director of the Laboratory of Tumor invasion and metastasis</investigator_title>
  </responsible_party>
  <keyword>hepatocellular carcinoma</keyword>
  <keyword>liver transplantation</keyword>
  <keyword>adenovirus-thymidine kinase</keyword>
  <keyword>gene therapy</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ganciclovir</mesh_term>
    <mesh_term>Ganciclovir triphosphate</mesh_term>
  </intervention_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/NCT02202564
org study id: LT-02
nct id: NCT02202564
lead sponsor: 
collaborator: 
HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and
      extrahepatic portal branches participated in the study. Patients were randomized allocated in
      liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received
      orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered
      to patients twice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival rate
time frame: up to 3-year
measure: Recurrence-free survival rate
time frame: up to 3-year
arm group label: LT+ADV-TK
arm group type: Experimental
description: Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.
arm group label: LT
arm group type: Active Comparator
description: Orthotopic liver transplantation
intervention type: Procedure
intervention name: LT
description: Orthotopic LT
arm group label: LT
arm group label: LT+ADV-TK
other name: liver transplantation
intervention type: Drug
intervention name: ADV-TK
arm group label: LT+ADV-TK
other name: adenovirus-thymidine kinase
intervention type: Drug
intervention name: ganciclovir
arm group label: LT+ADV-TK
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ding Ma, M.D.
role: Principal Investigator
affiliation: Huazhong University of Science and Technology
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Ding Ma
investigator title: Director of the Laboratory of Tumor invasion and metastasis
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Ganciclovir
mesh term: Ganciclovir triphosphate