<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/NCT02215837</url>
  </required_header>
  <id_info>
    <org_study_id>HYK-Gastric Cancer</org_study_id>
    <nct_id>NCT02215837</nct_id>
  </id_info>
  <brief_title>Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer</brief_title>
  <official_title>Randomized,Controlled,Multicenter Study of Autologous Tumor Lysate-pulsed Dendritic and Cytokine-induced Killer Cells(Ag-D-CIK) Combined With Chemotherapy for Gastric Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen Hornetcorn Bio-technology Company, LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jingzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shenzhen Hornetcorn Bio-technology Company, LTD</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined&#xD;
      with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK)&#xD;
      for gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      40 patients with stage Ⅰ～Ⅲ Gastric Cancer,who had received surgery and kept their tumor&#xD;
      tissue,will be randomly divided into group A（receive Ag-D-CIK treatment and chemotherapy) or&#xD;
      group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A&#xD;
      will receive 3 cycles of Ag-D-CIK treatment (every 1 months) and 4 cycles of chemotherapy&#xD;
      (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</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>Progress-free survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phenotypic analysis of T cells</measure>
    <time_frame>1 years</time_frame>
    <description>The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of adverse events</measure>
    <time_frame>1 years</time_frame>
    <description>According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Neoplasms</condition>
  <condition>Gastrointestinal Neoplasms</condition>
  <condition>Digestive System Neoplasms</condition>
  <condition>Gastrointestinal Diseases</condition>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ag-D-CIK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.</description>
    <arm_group_label>Ag-D-CIK</arm_group_label>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>FOLFOX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ag-D-CIK</intervention_name>
    <description>8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.</description>
    <arm_group_label>Ag-D-CIK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who can accept curative operations&#xD;
&#xD;
          -  18~80 years old&#xD;
&#xD;
          -  Histologically confirmed with gastric cancer at stage Ⅰ~Ⅲ&#xD;
&#xD;
          -  Patients who can accept radical gastrectomy;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin&lt;8.0 g/dL,White blood cell &lt;3 x 10^9/L;Platelet count &lt;75 x 10^9/L; ALT,&#xD;
             AST, BUN and Cr more than normal limits on 3.0 times&#xD;
&#xD;
          -  Known or suspected allergy to the investigational agent or any agent given in&#xD;
             association with this trial&#xD;
&#xD;
          -  Pregnant or lactating patients&#xD;
&#xD;
          -  Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or&#xD;
             TreponemaPallidun (TP) infection&#xD;
&#xD;
          -  Patients who are suffering from serious autoimmune disease&#xD;
&#xD;
          -  Patients who had used long time or are using immunosuppressant&#xD;
&#xD;
          -  Patients who had active infection&#xD;
&#xD;
          -  Patients who are suffering from serious organ dysfunction&#xD;
&#xD;
          -  Patients who are suffering from other cancer&#xD;
&#xD;
          -  Other situations that the researchers considered unsuitable for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hai Y Liu, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jingzhou Central Hospital Immunotherapy center</name>
      <address>
        <city>Jingzhou</city>
        <state>Hubei</state>
        <zip>434020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 23, 2016</last_update_submitted>
  <last_update_submitted_qc>May 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>D-CIK</keyword>
  <keyword>Autologous tumor lysate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02215837
org study id: HYK-Gastric Cancer
nct id: NCT02215837
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined
      with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK)
      for gastric cancer.
40 patients with stage Ⅰ～Ⅲ Gastric Cancer,who had received surgery and kept their tumor
      tissue,will be randomly divided into group A（receive Ag-D-CIK treatment and chemotherapy) or
      group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A
      will receive 3 cycles of Ag-D-CIK treatment (every 1 months) and 4 cycles of chemotherapy
      (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress-free survival
time frame: 3 years
measure: Overall survival
time frame: 3 years
measure: Quality of life (QOL)
time frame: 3 years
measure: Phenotypic analysis of T cells
time frame: 1 years
description: The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
measure: Severity of adverse events
time frame: 1 years
description: According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
arm group label: Chemotherapy
arm group type: Sham Comparator
description: After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.
arm group label: Ag-D-CIK
arm group type: Experimental
description: After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.
intervention type: Drug
intervention name: Chemotherapy
description: Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.
arm group label: Ag-D-CIK
arm group label: Chemotherapy
other name: FOLFOX
intervention type: Biological
intervention name: Ag-D-CIK
description: 8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.
arm group label: Ag-D-CIK
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hai Y Liu, Professor
role: Principal Investigator
affiliation: Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Stomach Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
sharing ipd: Undecided