<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/NCT03235167</url>
  </required_header>
  <id_info>
    <org_study_id>zsyy_zxsys2017-07</org_study_id>
    <nct_id>NCT03235167</nct_id>
  </id_info>
  <brief_title>Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy</brief_title>
  <official_title>Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy</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 observe the outcome of hepatocellular carcinoma patients under the combination treatment&#xD;
      of transcatheter arterial chemoembolization (TACE) and CpG DNA&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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>survival time</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>metastasis free survival time</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>CpG DNA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CpG DNA concentrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo concentrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CpG DNA</intervention_name>
    <description>CpG DNA concentrate</description>
    <arm_group_label>CpG DNA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transcatheter arterial chemoembolization</intervention_name>
    <description>transcatheter arterial chemoembolization (TACE) therapy for liver cancer</description>
    <arm_group_label>CpG DNA</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - Concentrate</intervention_name>
    <description>CpG DNA vehicle</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TNM (tumor node metastasis ) staging with non distant metastasis; no other tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having received previous treatment for liver cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 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>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>age, gender, cancer 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/NCT03235167
org study id: zsyy_zxsys2017-07
nct id: NCT03235167
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
to observe the outcome of hepatocellular carcinoma patients under the combination treatment
      of transcatheter arterial chemoembolization (TACE) and CpG DNA
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: survival time
time frame: 5 years
measure: metastasis free survival time
time frame: 5 years
arm group label: CpG DNA
arm group type: Experimental
description: CpG DNA concentrate
arm group label: placebo
arm group type: Placebo Comparator
description: placebo concentrate
intervention type: Drug
intervention name: CpG DNA
description: CpG DNA concentrate
arm group label: CpG DNA
intervention type: Procedure
intervention name: transcatheter arterial chemoembolization
description: transcatheter arterial chemoembolization (TACE) therapy for liver cancer
arm group label: CpG DNA
arm group label: placebo
intervention type: Drug
intervention name: Placebo - Concentrate
description: CpG DNA vehicle
arm group label: placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 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: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided
ipd description: age, gender, cancer staging