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/NCT06023797</url>
    </required_header>
    <id_info>
      <org_study_id>ZS-chest</org_study_id>
      <nct_id>NCT06023797</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Immunochemotherapy for Lung Cancer</brief_title>
    <official_title>Retrospective Research on Lung Cancer Patients Receiving Neoadjuvant Immunochemotherapy From Zhongshan Hospital Fudan University.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Zhongshan Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department&#xD;
        of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at&#xD;
        one application of PD-1 inhibitor.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2017</start_date>
    <completion_date type="Actual">July 2023</completion_date>
    <primary_completion_date type="Actual">November 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>2017-2023</time_frame>
      <description>Progression-free defined as status of recurrence of lung cancer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>2017-2023</time_frame>
      <description>Overall defined as the living status, alive or dead</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">83</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>MAICT</arm_group_label>
      <description>chemotherapy that included at one application of PD-1 inhibitor</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Neoadjuvant immunochemotherapy</intervention_name>
      <description>Patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.</description>
      <arm_group_label>MAICT</arm_group_label>
      <other_name>surgery</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients who received NAICT and were operated at the Department of Thoracic Surgery,&#xD;
          Zhongshan Hospital Fudan University between 2017 and 2022.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan&#xD;
               Hospital;&#xD;
  &#xD;
            2. At least one cycle of neoadjuvant treatment containing the immune drug PD-1&#xD;
               immunosuppressant was performed before surgery;&#xD;
  &#xD;
            3. Malignancy was present and confirmed in the pathology before treatment and after&#xD;
               surgery;&#xD;
  &#xD;
            4. The lung lesion was the primary lesion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. No lung surgery was performed until 2022.11;&#xD;
  &#xD;
            2. No preoperative neoadjuvant therapy was performed or recorded;&#xD;
  &#xD;
            3. Neoadjuvant therapy did not include immune drugs;&#xD;
  &#xD;
            4. Previous history of malignancy (including surgery and adjuvant therapy);&#xD;
  &#xD;
            5. Previous use of system-related immune medicines, such as immunosuppressants and&#xD;
               monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Zhencong Chen</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 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 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>neoadjuvant therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06023797
  org study id: ZS-chest
  nct id: NCT06023797
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department
        of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at
        one application of PD-1 inhibitor.
  observational model: Cohort
  time perspective: Retrospective
  measure: Progression-free survival (PFS)
  time frame: 2017-2023
  description: Progression-free defined as status of recurrence of lung cancer
  measure: Overall survival (OS)
  time frame: 2017-2023
  description: Overall defined as the living status, alive or dead
  arm group label: MAICT
  description: chemotherapy that included at one application of PD-1 inhibitor
  intervention type: Drug
  intervention name: Neoadjuvant immunochemotherapy
  description: Patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.
  arm group label: MAICT
  other name: surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: Undecided