<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/NCT03008304</url>
  </required_header>
  <id_info>
    <org_study_id>HANK-pancreas</org_study_id>
    <nct_id>NCT03008304</nct_id>
  </id_info>
  <brief_title>High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic 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 high-activity natural killer&#xD;
      immunotherapy to small metastases of pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      By enrolling patients with small metastases of pancreatic cancer adapted to enrolled&#xD;
      criteria, this study will document for the first time the safety and the short and long term&#xD;
      efficacy of high-activity natural killer 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">September 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>None (Open Label)</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>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>High-activity natural killer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the patients will receive multiple high-activity natural killer 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>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group, the patients will receive no special treatment. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High-activity natural killer</intervention_name>
    <description>Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.</description>
    <arm_group_label>High-activity 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; 2 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>Metastatic pancreatic cancer</keyword>
  <keyword>High-activity natural killer Immunotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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/NCT03008304
org study id: HANK-pancreas
nct id: NCT03008304
lead sponsor: 
collaborator: 
The aim of this study is the safety and efficacy of high-activity natural killer
      immunotherapy to small metastases of pancreatic cancer.
By enrolling patients with small metastases of pancreatic cancer adapted to enrolled
      criteria, this study will document for the first time the safety and the short and long term
      efficacy of high-activity natural killer 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: None (Open Label)
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: High-activity natural killer
arm group type: Experimental
description: In this group, the patients will receive multiple high-activity natural killer immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
arm group label: Control group
arm group type: No Intervention
description: In this group, the patients will receive no special treatment. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
intervention type: Drug
intervention name: High-activity natural killer
description: Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
arm group label: High-activity 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: Pancreatic Neoplasms