xml: <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/NCT06029829</url>
    </required_header>
    <id_info>
      <org_study_id>CTGU008</org_study_id>
      <nct_id>NCT06029829</nct_id>
    </id_info>
    <brief_title>The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.</brief_title>
    <official_title>The Clinical Value of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution in the Immunotherapy of Advanced Primary HCC Patients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xin-Hua Xu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China Three Gorges University, Yichang, China</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>
        Providing more theoretical basis for the prediction of the efficacy of advanced HCC and&#xD;
        helping select better advantaged population of HCC immunotherapy to maximize the benefits of&#xD;
        patients By exploring the relationship between the changes of PD-1 expression in peripheral&#xD;
        blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1&#xD;
        inhibitors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Exploring the expression of peripheral blood T lymphocyte PD-1 from an immunological&#xD;
        perspective as a potential reference marker for selecting immunotherapy in advanced HCC&#xD;
        patients, and elucidating the relationship between the level of peripheral blood T lymphocyte&#xD;
        PD-1 expression and survival outcomes after receiving immunotherapy. Additionally,&#xD;
        investigating whether there is consistency between the expression levels of PD-1 and PD-L1&#xD;
        and their impact on patients. Furthermore, exploring the correlation between the distribution&#xD;
        of T cell subsets and the efficacy of immunotherapy to provide new theoretical evidence for&#xD;
        the selection of target populations for immunotherapy and new clinical screening indicators&#xD;
        for patient prognosis assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 12, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.</measure>
      <time_frame>24 months</time_frame>
      <description>PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sintilimab</intervention_name>
      <description>Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy</description>
      <arm_group_label>Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willing to participate in the clinical study, fully understand and be informed about&#xD;
               the study, and sign the informed consent form;&#xD;
  &#xD;
            -  Age between 18 and 75 years, male or female;&#xD;
  &#xD;
            -  Strictly meet the clinical diagnostic criteria for hepatocellular carcinoma (HCC),&#xD;
               confirmed by histology or cytology, with at least one lesion meeting the RECIST 1.1&#xD;
               criteria on CT or MRI examination;&#xD;
  &#xD;
            -  No prior targeted therapy, immunotherapy, or systemic chemotherapy for liver cancer&#xD;
               before admission;&#xD;
  &#xD;
            -  Child-Pugh A liver function; Barcelona Clinic Liver Cancer (BCLC) stage B or C;&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;&#xD;
  &#xD;
            -  Normal function of major organs;&#xD;
  &#xD;
            -  Expected survival time of at least 12 weeks or more.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have not previously received treatment with Sintilimab or any other PD-L1&#xD;
               or PD-1 antagonist;&#xD;
  &#xD;
            -  Patients with any active autoimmune disease or a history of autoimmune disease, or a&#xD;
               history of immunodeficiency;&#xD;
  &#xD;
            -  Patients requiring the use of immunosuppressive drugs;&#xD;
  &#xD;
            -  Known history of allergy to the formulation of Sintilimab or any other component of&#xD;
               the antibody formulation;&#xD;
  &#xD;
            -  Patients with other malignant tumors.&#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_contact>
      <last_name>Xinhua Xu, Master</last_name>
      <phone>13986747496</phone>
      <phone_ext>86</phone_ext>
      <email>2732774352@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Siqi Liu, Postgr</last_name>
      <phone>18272447628</phone>
      <phone_ext>86</phone_ext>
      <email>1301915712@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University</name>
        <address>
          <city>Yichang</city>
          <state>Hubei</state>
          <zip>443003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xinhua Xu</last_name>
        <phone>+8613986747496</phone>
        <phone_ext>+8613986747496</phone_ext>
        <email>2732774352@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>China Three Gorges University, Yichang, China</investigator_affiliation>
      <investigator_full_name>Xin-Hua Xu</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>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029829
  org study id: CTGU008
  nct id: NCT06029829
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Providing more theoretical basis for the prediction of the efficacy of advanced HCC and
        helping select better advantaged population of HCC immunotherapy to maximize the benefits of
        patients By exploring the relationship between the changes of PD-1 expression in peripheral
        blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1
        inhibitors.
  Exploring the expression of peripheral blood T lymphocyte PD-1 from an immunological
        perspective as a potential reference marker for selecting immunotherapy in advanced HCC
        patients, and elucidating the relationship between the level of peripheral blood T lymphocyte
        PD-1 expression and survival outcomes after receiving immunotherapy. Additionally,
        investigating whether there is consistency between the expression levels of PD-1 and PD-L1
        and their impact on patients. Furthermore, exploring the correlation between the distribution
        of T cell subsets and the efficacy of immunotherapy to provide new theoretical evidence for
        the selection of target populations for immunotherapy and new clinical screening indicators
        for patient prognosis assessment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
  time frame: 24 months
  description: PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
  arm group label: Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy
  arm group type: Experimental
  description: Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy
  intervention type: Drug
  intervention name: Sintilimab
  description: Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy
  arm group label: Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xinhua Xu, Master
  phone: 13986747496
  phone ext: 86
  email: 2732774352@qq.com
  last name: Siqi Liu, Postgr
  phone: 18272447628
  phone ext: 86
  email: 1301915712@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: China Three Gorges University, Yichang, China
  investigator full name: Xin-Hua Xu
  investigator title: professor
  mesh term: Carcinoma, Hepatocellular