<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/NCT03282435</url>
  </required_header>
  <id_info>
    <org_study_id>zsyy_zxsys2018-01</org_study_id>
    <nct_id>NCT03282435</nct_id>
  </id_info>
  <brief_title>Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody</brief_title>
  <official_title>Treatment of Non-small Cell Lung Cancer With CIK Cells Blocked by PD-1 Antibody</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalian University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular&#xD;
      treatment with PD-1 blocking on top of the standard therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>metastasis-free survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>CIK cells with PD-1 blocking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CIK cells without PD-1 blocking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CIK cells with PD-1 blocking</intervention_name>
    <description>CIK cellular therapy with PD-1 blocking</description>
    <arm_group_label>CIK cells with PD-1 blocking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard lung cancer treament</intervention_name>
    <description>standard non-small cell lung cancer treatment: surgery, chemotherapy</description>
    <arm_group_label>CIK cells with PD-1 blocking</arm_group_label>
    <arm_group_label>CIK cells without PD-1 blocking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CIK cells without PD-1 blocking</intervention_name>
    <description>CIK cellular therapy without PD-1 blocking</description>
    <arm_group_label>CIK cells without PD-1 blocking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-small cell lung cancer;&#xD;
&#xD;
          -  more than 50% tumor tissues positive with PD-L1;&#xD;
&#xD;
          -  EGFR and ALK wild type&#xD;
&#xD;
          -  no other tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with systematic diseases shortening survival&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>xiaolin Yuan</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Affiliated Zhongshan Hospital of Dalian University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>haoren wang</last_name>
    <phone>86-041162893507</phone>
    <email>haoren_wang@yahoo.com</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>age, gender, tumor staging</ipd_description>
  </patient_data>
  <!-- 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/NCT03282435
org study id: zsyy_zxsys2018-01
nct id: NCT03282435
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular
      treatment with PD-1 blocking on top of the standard therapy
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: progression-free survival
time frame: 5 years
measure: metastasis-free survival
time frame: 5 years
arm group label: CIK cells with PD-1 blocking
arm group type: Experimental
description: CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment
arm group label: CIK cells without PD-1 blocking
arm group type: Active Comparator
description: CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive
intervention type: Biological
intervention name: CIK cells with PD-1 blocking
description: CIK cellular therapy with PD-1 blocking
arm group label: CIK cells with PD-1 blocking
intervention type: Other
intervention name: standard lung cancer treament
description: standard non-small cell lung cancer treatment: surgery, chemotherapy
arm group label: CIK cells with PD-1 blocking
arm group label: CIK cells without PD-1 blocking
intervention type: Biological
intervention name: CIK cells without PD-1 blocking
description: CIK cellular therapy without PD-1 blocking
arm group label: CIK cells without PD-1 blocking
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: xiaolin Yuan
role: Principal Investigator
affiliation: The Affiliated Zhongshan Hospital of Dalian University
last name: haoren wang
phone: 86-041162893507
email: haoren_wang@yahoo.com
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Yes
ipd description: age, gender, tumor staging