<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/NCT04476641</url>
  </required_header>
  <id_info>
    <org_study_id>B2016-036-02</org_study_id>
    <nct_id>NCT04476641</nct_id>
  </id_info>
  <brief_title>A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors</brief_title>
  <acronym>DC-CIK</acronym>
  <official_title>A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Main purpose of this study is through comparing with the external control, evaluation of&#xD;
      autologous D - CIK cells immunotherapy to finish after conventional treatment of liver&#xD;
      cancer, renal clear cell carcinoma and nasopharyngeal carcinoma, lung cancer, colon cancer,&#xD;
      breast cancer patients with the clinical efficacy and safety of study population, including&#xD;
      clinical liver, renal clear cell carcinoma and nasopharyngeal carcinoma, lung cancer, colon&#xD;
      cancer, breast cancer after conventional treatment (surgery, chemotherapy and radiotherapy)&#xD;
      patients.The primary outcome measures were overall survival and progression-free survival,&#xD;
      while the secondary outcome measures were overall response rate and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, single arm phase II clinical research, to evaluate the self D - CIK&#xD;
      cells to treat liver cancer, renal clear cell carcinoma, nasopharyngeal carcinoma, lung&#xD;
      cancer, colorectal cancer, breast cancer patient safety and efficacy of plan participants&#xD;
      included 1372 cases of the subjects, experimental group 686 cases, control group 686 cases,&#xD;
      control group adopts the liver, renal clear cell carcinoma, nasopharyngeal carcinoma, lung&#xD;
      cancer, colorectal cancer, breast cancer patients after conventional treatment (surgery,&#xD;
      chemotherapy and radiotherapy) did not receive D - CIK cell therapy of external control&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 6, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OS and PFS</measure>
    <time_frame>The enrollment period was 3 years and the follow-up period was 5 years</time_frame>
    <description>Overall survival and progression-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR, CR+PR</measure>
    <time_frame>The enrollment period was 3 years and the follow-up period was 5 years</time_frame>
    <description>Overall response rate and quality of life</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">686</enrollment>
  <condition>Liver Cancer</condition>
  <condition>Kidney Cancer</condition>
  <condition>Nasopharyngeal Cancer</condition>
  <condition>Lung Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>DC-CIK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CELL</intervention_name>
    <description>inject the DC-CIK(dendritic cell activated and cytokine induced killer cell)</description>
    <arm_group_label>DC-CIK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Patients diagnosed with liver cancer, renal clear cell carcinoma, nasopharyngeal&#xD;
             carcinoma, lung cancer, colorectal cancer, breast cancer and nasopharyngeal carcinoma&#xD;
             by imaging examination, tissue and/or cytology, and patients after conventional&#xD;
             treatment (surgery, chemotherapy and radiotherapy); (2) No history of other tumors&#xD;
             (except surgically cured skin squamous cell carcinoma).&#xD;
&#xD;
             (3) Male or female, aged over 18 and under 75 (including 18 and 75 years old). (4)&#xD;
             Physical condition: ECOG score 0 or 1. (5) Expected survival time ≥ 6 months, and&#xD;
             follow-up was available. (6) Within 7 days before the start of treatment, the results&#xD;
             of blood routine, liver and kidney function, and hemagglutination laboratory&#xD;
             examination meet the following standards:White blood cell (WBC) ≥ 3.5×109/L, platelet&#xD;
             (PLT) ≥ 80×109/L, Neutropene (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90g/L, aspartic&#xD;
             acid transaminase (AST) &lt; 2.5× normal upper limit (ULN) (liver metastasis &lt; 5×ULN),&#xD;
             alanine transaminase (ALT) &lt; 2.5×ULN (liver metastasis &lt; 5×ULN), total bilirubin&#xD;
             (TIBC) &lt; 1.5×ULN,Serum creatinine (CR) &lt; 1.0×ULN, prothrombin time, partial thrombin&#xD;
             time, plasma fibrinogen, thrombin time were within the normal range.&#xD;
&#xD;
             (7) Female subjects must use effective contraceptives (such as prescription oral&#xD;
             contraceptives, injectable contraceptives, iUDS, double blocking, contraceptive patch,&#xD;
             male partner sterilization, etc.) throughout the study period;Serum or urine pregnancy&#xD;
             test results must be negative during screening and throughout the study period.&#xD;
&#xD;
             (8) Male subjects should take effective contraceptive measures within 1 month after&#xD;
             receiving treatment and completing chemotherapy.&#xD;
&#xD;
             (9) Be willing to comply with the prohibitions and restrictions stipulated in the&#xD;
             research plan.&#xD;
&#xD;
             (10) The subjects have signed an informed consent, stating that they understand the&#xD;
             purpose, procedure and content of the study and are willing to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Patients with clinical symptoms of brain metastasis (except after radiotherapy).&#xD;
&#xD;
             (2) There is an active viral or bacterial infection that cannot be controlled with&#xD;
             appropriate anti-infective therapy.&#xD;
&#xD;
             (3) Known to be serologically positive for HIV, syphilis, active HBV or HCV infection.&#xD;
&#xD;
             (4) Having a mental illness or other medical condition, such as uncontrollable heart&#xD;
             or lung disease, diabetes, etc., and failing to comply with the requirements of&#xD;
             research treatment and monitoring.&#xD;
&#xD;
             (5) Those who are known to be allergic to any component in cultured D-CIK cells.&#xD;
&#xD;
             (6) Active rheumatic diseases. (7) Organ transplanters. (8) Poor compliance. (9) Women&#xD;
             during pregnancy. (10) Lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianchuan Xia</last_name>
    <role>Study Director</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianchuan Xia, doctor</last_name>
    <phone>02087343404</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Tang</last_name>
      <phone>02087343404</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jianchuan Xia</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
  </condition_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/NCT04476641
org study id: B2016-036-02
nct id: NCT04476641
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Main purpose of this study is through comparing with the external control, evaluation of
      autologous D - CIK cells immunotherapy to finish after conventional treatment of liver
      cancer, renal clear cell carcinoma and nasopharyngeal carcinoma, lung cancer, colon cancer,
      breast cancer patients with the clinical efficacy and safety of study population, including
      clinical liver, renal clear cell carcinoma and nasopharyngeal carcinoma, lung cancer, colon
      cancer, breast cancer after conventional treatment (surgery, chemotherapy and radiotherapy)
      patients.The primary outcome measures were overall survival and progression-free survival,
      while the secondary outcome measures were overall response rate and quality of life.
This is a single center, single arm phase II clinical research, to evaluate the self D - CIK
      cells to treat liver cancer, renal clear cell carcinoma, nasopharyngeal carcinoma, lung
      cancer, colorectal cancer, breast cancer patient safety and efficacy of plan participants
      included 1372 cases of the subjects, experimental group 686 cases, control group 686 cases,
      control group adopts the liver, renal clear cell carcinoma, nasopharyngeal carcinoma, lung
      cancer, colorectal cancer, breast cancer patients after conventional treatment (surgery,
      chemotherapy and radiotherapy) did not receive D - CIK cell therapy of external control
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: OS and PFS
time frame: The enrollment period was 3 years and the follow-up period was 5 years
description: Overall survival and progression-free survival
measure: ORR, CR+PR
time frame: The enrollment period was 3 years and the follow-up period was 5 years
description: Overall response rate and quality of life
arm group label: DC-CIK
arm group type: Experimental
intervention type: Other
intervention name: CELL
description: inject the DC-CIK(dendritic cell activated and cytokine induced killer cell)
arm group label: DC-CIK
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianchuan Xia
role: Study Director
affiliation: Sun Yat-sen University
last name: Jianchuan Xia, doctor
phone: 02087343404
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Jianchuan Xia
investigator title: professor
mesh term: Kidney Neoplasms
mesh term: Nasopharyngeal Neoplasms
mesh term: Nasopharyngeal Carcinoma
sharing ipd: No