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/NCT06011993</url>
    </required_header>
    <id_info>
      <org_study_id>neoHNSCC</org_study_id>
      <nct_id>NCT06011993</nct_id>
    </id_info>
    <brief_title>Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）</brief_title>
    <official_title>Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
    <oversight_info>
      <has_dmc>No</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>
        This is a retrospective, single-arm study that assesses the efficacy and safety of&#xD;
        neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck&#xD;
        Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant&#xD;
        immunochemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a retrospective, single-arm study that assesses the efficacy and safety of&#xD;
        neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck&#xD;
        Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant&#xD;
        immunochemotherapy. Patients with untreated, operable, or potentially resectable HNSCC will&#xD;
        be included.The pathological results, adverse events and other information of eligible&#xD;
        patients will be collected.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 19, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse events</measure>
      <time_frame>6 months</time_frame>
      <description>Adverse events should be collected, followed up and reported in accordance with prescribed procedures.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Major Pathological Response</measure>
      <time_frame>6 months</time_frame>
      <description>MPR, defined as ≤10% of residual surviving tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete Pathological Response</measure>
      <time_frame>6 months</time_frame>
      <description>CPR, defined as no residual survivable tumor cells</description>
    </secondary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Head and Neck Squamous Cell Carcinoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Head and neck squamous cell carcinoma，HNSCC&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-80, male or female；&#xD;
  &#xD;
            -  Cytologically or histologically diagnosed squamous cell carcinoma (except mixed&#xD;
               squamous cell carcinoma)；&#xD;
  &#xD;
            -  There was at least one radiographically measurable lesion according to the solid tumor&#xD;
               response Evaluation Criteria (RECIST version 1.1)；&#xD;
  &#xD;
            -  Patients with untreated, operable, or potentially resectable head and neck squamous&#xD;
               cell carcinoma；&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5&#xD;
               years prior to first administration (excluding basal cell carcinoma of the skin after&#xD;
               radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ&#xD;
               after radical resection)；&#xD;
  &#xD;
            -  Currently participating in an interventional clinical study or has received another&#xD;
               investigational drug or has used investigational devices in the 4 weeks prior to&#xD;
               initial dosing；&#xD;
  &#xD;
            -  Evidence of medical history or disease that may interfere with trial results, prevent&#xD;
               participants from participating fully in the study, abnormal treatment or laboratory&#xD;
               test values, or other conditions that the investigator deems unsuitable for&#xD;
               enrollment；&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Fuming Qiu, PhD</last_name>
      <phone>13858005908</phone>
      <email>qiufuming@zju.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fuming Qiu, PhD</last_name>
        <phone>13858005908</phone>
        <email>qiufuming@zju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HNSCC</keyword>
    <keyword>Neoadjuvant immunochemotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</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/NCT06011993
  org study id: neoHNSCC
  nct id: NCT06011993
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a retrospective, single-arm study that assesses the efficacy and safety of
        neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck
        Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant
        immunochemotherapy.
  This is a retrospective, single-arm study that assesses the efficacy and safety of
        neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck
        Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant
        immunochemotherapy. Patients with untreated, operable, or potentially resectable HNSCC will
        be included.The pathological results, adverse events and other information of eligible
        patients will be collected.
  observational model: Other
  time perspective: Retrospective
  measure: Adverse events
  time frame: 6 months
  description: Adverse events should be collected, followed up and reported in accordance with prescribed procedures.
  measure: Major Pathological Response
  time frame: 6 months
  description: MPR, defined as ≤10% of residual surviving tumors
  measure: Complete Pathological Response
  time frame: 6 months
  description: CPR, defined as no residual survivable tumor cells
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Fuming Qiu, PhD
  phone: 13858005908
  email: qiufuming@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Squamous Cell Carcinoma of Head and Neck