<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/NCT03008343</url>
  </required_header>
  <id_info>
    <org_study_id>IRE-NK-Liver</org_study_id>
    <nct_id>NCT03008343</nct_id>
  </id_info>
  <brief_title>Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuda Cancer Hospital, Guangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shenzhen Hank Bioengineering Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fuda Cancer Hospital, Guangzhou</source>
  <brief_summary>
    <textblock>
      The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus&#xD;
      natural killer (NK) immunotherapy to recurrent liver cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      By enrolling patients with recurrent liver cancer adapted to enrolled criteria, this study&#xD;
      will document for the first time the safety and the short and long term efficacy of the&#xD;
      combined therapy using IRE and NK cells.&#xD;
&#xD;
      The safety will be evaluated by statistics of adverse reactions. The efficacy will be&#xD;
      evaluated according to local relief degree, progress free survival (PFS) and overall survival&#xD;
      (OS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <phase>Phase 1/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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relief degree of tumors</measure>
    <time_frame>3 months</time_frame>
    <description>It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress free survival（PFS）</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival（OS）</measure>
    <time_frame>3 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Recurrent Liver Carcinoma</condition>
  <arm_group>
    <arm_group_label>Electroporation and natural killer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electroporation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, the patients will receive regular irreversible electroporation (IRE) treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Irreversible Electroporation</intervention_name>
    <description>One kind of electric ablation machine from Angiodynamic company (USA)</description>
    <arm_group_label>Electroporation</arm_group_label>
    <arm_group_label>Electroporation and natural killer</arm_group_label>
    <other_name>IRE, NanoKnife</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Natural killer</intervention_name>
    <description>Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.</description>
    <arm_group_label>Electroporation and natural killer</arm_group_label>
    <other_name>HANK cell</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All standard therapies have failed according to NCCN guidelines or the patient refuses&#xD;
             standard therapies after cancer recurrence&#xD;
&#xD;
          -  Body tumor 1-6, the maximum tumor length &lt; 5 cm&#xD;
&#xD;
          -  KPS ≥ 70, lifespan &gt; 6 months&#xD;
&#xD;
          -  Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥&#xD;
             2×109/L, hemoglobin ≥ 80 g/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiac pacemaker&#xD;
&#xD;
          -  Patients with brain metastasis&#xD;
&#xD;
          -  Patients with grade 3 hypertension or diabetic complication, severe cardiac and&#xD;
             pulmonary dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fuda cancer institute of Fuda cancer hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510665</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Irreversible Electroporation</keyword>
  <keyword>NK Immunotherapy</keyword>
  <keyword>Recurrent Liver Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Recurrence</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/NCT03008343
org study id: IRE-NK-Liver
nct id: NCT03008343
lead sponsor: 
collaborator: 
The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus
      natural killer (NK) immunotherapy to recurrent liver cancer.
By enrolling patients with recurrent liver cancer adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of the
      combined therapy using IRE and NK cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Relief degree of tumors
time frame: 3 months
description: It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
measure: Progress free survival（PFS）
time frame: 1 year
measure: Overall survival（OS）
time frame: 3 year
arm group label: Electroporation and natural killer
arm group type: Experimental
description: In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
arm group label: Electroporation
arm group type: Active Comparator
description: In this group, the patients will receive regular irreversible electroporation (IRE) treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
intervention type: Device
intervention name: Irreversible Electroporation
description: One kind of electric ablation machine from Angiodynamic company (USA)
arm group label: Electroporation
arm group label: Electroporation and natural killer
other name: IRE, NanoKnife
intervention type: Biological
intervention name: Natural killer
description: Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
arm group label: Electroporation and natural killer
other name: HANK cell
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Hepatocellular
mesh term: Recurrence