<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/NCT03002831</url>
  </required_header>
  <id_info>
    <org_study_id>HenanCH CIK02</org_study_id>
    <nct_id>NCT03002831</nct_id>
  </id_info>
  <brief_title>Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer</brief_title>
  <official_title>Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henan Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henan Cancer Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Cytokine induced killer cells combined&#xD;
      chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and&#xD;
      a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to&#xD;
      pancreatic cancer especially advanced stage patients. This study is a prospective,&#xD;
      randomized, open, single center phase II study. The investigators try to evaluate the&#xD;
      efficacy and safety of this treatment mode.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study halted prematurely and will not resume&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</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>Overall Survival</measure>
    <time_frame>From the date of randomization to the date of death from any cause up to 36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From the date of randomization to the date of first documented progression up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by Questionnaire</measure>
    <time_frame>one year by questionnaire</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>CIK combined chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cytokine-induced Killer Cells</intervention_name>
    <arm_group_label>CIK combined chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tegafur-Gimeracil-Oteracil Potassium</intervention_name>
    <arm_group_label>CIK combined chemotherapy</arm_group_label>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. No less than 18 years old&#xD;
&#xD;
          2. Karnofsky Performance Status over 60&#xD;
&#xD;
          3. Life expectancy more than three months&#xD;
&#xD;
          4. Pathological diagnosed as pancreatic epithelial cell carcinoma&#xD;
&#xD;
          5. Recurrence after surgery or unresectable&#xD;
&#xD;
          6. No experienced chemotherapy or the interval between the last adjuvant chemotherapy and&#xD;
             relapse is at least 6 months&#xD;
&#xD;
          7. Measurable lesions (by CT or MRI)&#xD;
&#xD;
          8. No serious mental disorders&#xD;
&#xD;
          9. Adequate organ and bone marrow functions&#xD;
&#xD;
         10. No other serious and the conflict diseases(such as autoimmune diseases,&#xD;
             immunodeficiency, organ transplantation)&#xD;
&#xD;
         11. No other malignant tumor history&#xD;
&#xD;
         12. Informed consent and willing to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received immunosuppressants or glucocorticoid treatment&#xD;
&#xD;
          2. Uncontrolled severe infection or unhealed wound caused by suppurative inflammation&#xD;
&#xD;
          3. Heart disease, insufficient heart function, II degree heart block or occurred&#xD;
             myocardial infarction in 6 months&#xD;
&#xD;
          4. Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve&#xD;
             volume under 80% of the expected value&#xD;
&#xD;
          5. Other malignant tumor history&#xD;
&#xD;
          6. Transaminase&gt;2.5ULN or bilirubin&gt;3ULN or creatinine &gt;1.25ULN&#xD;
&#xD;
          7. Pregnant or lactating women&#xD;
&#xD;
          8. Obvious bleeding tendency&#xD;
&#xD;
          9. Participated other clinical trails in 1 month&#xD;
&#xD;
         10. Other unsuitable conditions: HIV infection, intravenous drug abusers, etc&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Quanli Gao, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Cancer Hospital of Zhengzhou University &amp; Henan Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Affiliated Cancer Hospital of Zhengzhou University &amp; Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30.</citation>
    <PMID>26741729</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.</citation>
    <PMID>26842696</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>March 31, 2020</last_update_submitted>
  <last_update_submitted_qc>March 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CIK</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Pancreatic Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tegafur</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03002831
org study id: HenanCH CIK02
nct id: NCT03002831
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Cytokine induced killer cells combined
      chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.
Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and
      a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to
      pancreatic cancer especially advanced stage patients. This study is a prospective,
      randomized, open, single center phase II study. The investigators try to evaluate the
      efficacy and safety of this treatment mode.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: From the date of randomization to the date of death from any cause up to 36 months
measure: Progression Free Survival
time frame: From the date of randomization to the date of first documented progression up to 24 months
measure: Quality of life assessed by Questionnaire
time frame: one year by questionnaire
arm group label: CIK combined chemotherapy
arm group type: Experimental
description: Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.
arm group label: Chemotherapy
arm group type: Active Comparator
description: Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w
intervention type: Biological
intervention name: Cytokine-induced Killer Cells
arm group label: CIK combined chemotherapy
intervention type: Drug
intervention name: Tegafur-Gimeracil-Oteracil Potassium
arm group label: CIK combined chemotherapy
arm group label: Chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Quanli Gao, Ph.D.
role: Principal Investigator
affiliation: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
facility: 
country: China
citation: Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30.
PMID: 26741729
citation: Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.
PMID: 26842696
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Tegafur
sharing ipd: No