<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/NCT02202928</url>
  </required_header>
  <id_info>
    <org_study_id>HYK-Colorectal Cancer</org_study_id>
    <nct_id>NCT02202928</nct_id>
  </id_info>
  <brief_title>Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer</brief_title>
  <official_title>Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen Hornetcorn Bio-technology Company, LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed&#xD;
      dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 patients with stageⅠ~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be&#xD;
      randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or&#xD;
      group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1.&#xD;
      Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells&#xD;
      treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive&#xD;
      only 4 cycles chemo-radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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 year</time_frame>
    <description>The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Neoplasms</condition>
  <condition>Intestinal Neoplasms</condition>
  <condition>Digestive System Neoplasms</condition>
  <condition>Gastrointestinal Diseases</condition>
  <arm_group>
    <arm_group_label>Chemo-radiotherapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DC-CIK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DC-CIK</intervention_name>
    <description>8×10^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.</description>
    <arm_group_label>DC-CIK</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>45~50 Gy in 25-28 fractions.</description>
    <arm_group_label>Chemo-radiotherapy</arm_group_label>
    <arm_group_label>DC-CIK</arm_group_label>
  </intervention>
  <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>Chemo-radiotherapy</arm_group_label>
    <arm_group_label>DC-CIK</arm_group_label>
    <other_name>FOLFOX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18~80 years old;&#xD;
&#xD;
          -  Histologically confirmed with colorectal cancer at stage Ⅰ~Ⅲ;&#xD;
&#xD;
          -  Patients who can accept curative operations;&#xD;
&#xD;
          -  Patients who have a life expectancy of at least 3 months;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin&lt;8.0 g/dL,Platelet count &lt;75 x 10^9/L; ALT, AST, BUN and Cr more than normal&#xD;
             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;
          -  History of organ allograft;&#xD;
&#xD;
          -  Patients who had distant metastases;&#xD;
&#xD;
          -  Patients who had active infection;&#xD;
&#xD;
          -  Prior use of any anti-cancer treatment in 30 days;&#xD;
&#xD;
          -  Now or recently will join another experimental clinical study ;&#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>Ke N Zhang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jingzhou Central Hospital</affiliation>
  </overall_official>
  <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>July 2015</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>December 23, 2015</last_update_submitted>
  <last_update_submitted_qc>December 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal cancer</keyword>
  <keyword>DC-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>Colorectal Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Intestinal Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</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/NCT02202928
org study id: HYK-Colorectal Cancer
nct id: NCT02202928
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed
      dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).
60 patients with stageⅠ~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be
      randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or
      group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1.
      Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells
      treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive
      only 4 cycles chemo-radiotherapy.
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 year
description: The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
arm group label: Chemo-radiotherapy
arm group type: Sham Comparator
description: After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
arm group label: DC-CIK
arm group type: Experimental
description: After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.
intervention type: Biological
intervention name: DC-CIK
description: 8×10^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.
arm group label: DC-CIK
intervention type: Radiation
intervention name: Radiotherapy
description: 45~50 Gy in 25-28 fractions.
arm group label: Chemo-radiotherapy
arm group label: DC-CIK
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: Chemo-radiotherapy
arm group label: DC-CIK
other name: FOLFOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ke N Zhang, Professor
role: Principal Investigator
affiliation: Jingzhou Central Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Intestinal Neoplasms
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases