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/NCT05964101</url>
    </required_header>
    <id_info>
      <org_study_id>ES-2023-062-03</org_study_id>
      <nct_id>NCT05964101</nct_id>
    </id_info>
    <brief_title>Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma</brief_title>
    <acronym>GALAXY-1</acronym>
    <official_title>Neoadjuvant Anti-PD-1 Drug Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Guangzhou Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab +&#xD;
        carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell&#xD;
        carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary tracheal tumors are rare, comprising 0.01-0.4% of all cancer cases. Most airway&#xD;
        tumors present with non-specific symptoms, such as shortness of breath and a sore throat,&#xD;
        which may not be attributable to the tumors themselves, leading to diagnostic delay. With&#xD;
        limited treatment options, surgical resection is considered the cornerstone therapy.&#xD;
        Neoadjuvant therapy is recommended as standard treatment for the early stages (stage IB/II)&#xD;
        and locally advanced stages (stage IIIA) of non-small cell lung cancer (NSCLC). Whether&#xD;
        neoadjuvant therapy affects subsequent pathological or surgical outcomes of primary tracheal&#xD;
        tumors remains unclear. This study aimed to characterize the outcomes of neoadjuvant therapy&#xD;
        for the treatment of primary tracheal squamous cell carcinoma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>
      <intervention_model_description>Single Group Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Major pathologic response (MPR)</measure>
      <time_frame>up to 4 months</time_frame>
      <description>MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety: frequency of severe adverse events</measure>
      <time_frame>up to 5 months</time_frame>
      <description>The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>up to 24 months</time_frame>
      <description>PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>up to 60 months</time_frame>
      <description>It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>up to 60 months</time_frame>
      <description>The proportion of patients whose best overall remission (BOR) is CR, PR or disease stable (SD) according to RECISTv1.1 evaluation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of remission (DOR)</measure>
      <time_frame>up to 60 months</time_frame>
      <description>According to the time from the first recording of objective remission to relapse or death from any cause determined by RECISTv1.1, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>R0 rate</measure>
      <time_frame>up to 4 months</time_frame>
      <description>There were no visible tumors in the surgical margin, and the tumor cells in the surgical margin within 1mm were negative under the microscope</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Neoplasms</condition>
    <condition>Carcinoma, Squamous</condition>
    <condition>Antineoplastic Agents</condition>
    <arm_group>
      <arm_group_label>Nivolumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neoadjuvant treatment stage: Nivolumab 360mg, Carboplatin AUC5+ paclitaxel 100 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with primary tracheal squamous cell carcinoma received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nivolumab Injection [Opdivo]</intervention_name>
      <description>Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel</description>
      <arm_group_label>Nivolumab</arm_group_label>
      <other_name>carboplatin</other_name>
      <other_name>paclitaxel</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological&#xD;
               examination&#xD;
  &#xD;
            2. PET-CT confirmed no metastasis;&#xD;
  &#xD;
            3. ECOG physical status score 0-1;&#xD;
  &#xD;
            4. Bronchoscopy, and chest CT is evaluated as early or locally advanced tracheal&#xD;
               malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant&#xD;
               therapy.&#xD;
  &#xD;
            5. Age ≥ 18 years;&#xD;
  &#xD;
            6. Have one measurable lesion at least;&#xD;
  &#xD;
            7. Good function of other major organs (liver, kidney, blood system, etc.):-absolute&#xD;
               neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L).&#xD;
               Note: patients shall not receive blood transfusion or growth factor support within 14&#xD;
               days before blood collection during the screening period;-International standardized&#xD;
               ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated&#xD;
               partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN&#xD;
               (Gilbert syndrome patients with total bilirubin must be &lt; 3×ULN). Fertile female&#xD;
               patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or&#xD;
               liver metastasis with AST and ALT ≤ 5 × ULN&#xD;
  &#xD;
            8. Fertile female patients must voluntarily take effective contraceptive measures more&#xD;
               than 120 days after chemotherapy or the last administration of Nivolumab, whichever is&#xD;
               later, and the urine or serum pregnancy test results less than 7 days before entering&#xD;
               the group were negative. Unsterilized male patients must voluntarily take effective&#xD;
               contraceptive measures ≥ 120 days after chemotherapy or the last administration of&#xD;
               Nivolumab, whichever is the latter.&#xD;
  &#xD;
            9. Sign informed consent;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any Chinese herbal medicine used to control cancer was used within 14 days before the&#xD;
               first administration of the study drug;&#xD;
  &#xD;
            2. Patients with other malignant tumors in the five years before the start of this trial.&#xD;
  &#xD;
            3. Complicated with unstable systemic diseases, including active infections, uncontrolled&#xD;
               hypertension, unstable angina pectoris, congestive heart failure [higher than II (New&#xD;
               York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;&#xD;
  &#xD;
            4. Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome&#xD;
               requiring systemic treatment;&#xD;
  &#xD;
            5. A history of active bleeding or embolism within 6 months, or received thrombolysis or&#xD;
               anticoagulation therapy, or the researchers believe that there is an obvious tendency&#xD;
               of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding,&#xD;
               local active ulcer lesions, etc.);&#xD;
  &#xD;
            6. Had is suffering from nephrotic syndrome&#xD;
  &#xD;
            7. Allergic to experimental drugs;&#xD;
  &#xD;
            8. Complicated with HIV infection or active hepatitis.&#xD;
  &#xD;
            9. Vaccination within 4 weeks before the start of this trial;&#xD;
  &#xD;
           10. Those who had undergone other major operations or severe injuries within the previous&#xD;
               2 months;&#xD;
  &#xD;
           11. Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal&#xD;
               puncture drainage within 2 weeks before admission;&#xD;
  &#xD;
           12. Pregnant or lactating women;&#xD;
  &#xD;
           13. Those with neurological diseases or mental disorders.&#xD;
  &#xD;
           14. Participated in another therapeutic clinical study at the same time;&#xD;
  &#xD;
           15. Other researchers did not consider it appropriate to enroll in the group.&#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>Shuben Li, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shuben Li, PhD</last_name>
      <phone>+8613500030280</phone>
      <email>13500030280@163.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
      <investigator_full_name>Shuben Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>tracheal tumor</keyword>
    <keyword>neoadjuvant immunochemotherapy</keyword>
    <keyword>surgery</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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Carboplatin</mesh_term>
      <mesh_term>Nivolumab</mesh_term>
    </intervention_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/NCT05964101
  org study id: ES-2023-062-03
  nct id: NCT05964101
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab +
        carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell
        carcinoma.
  Primary tracheal tumors are rare, comprising 0.01-0.4% of all cancer cases. Most airway
        tumors present with non-specific symptoms, such as shortness of breath and a sore throat,
        which may not be attributable to the tumors themselves, leading to diagnostic delay. With
        limited treatment options, surgical resection is considered the cornerstone therapy.
        Neoadjuvant therapy is recommended as standard treatment for the early stages (stage IB/II)
        and locally advanced stages (stage IIIA) of non-small cell lung cancer (NSCLC). Whether
        neoadjuvant therapy affects subsequent pathological or surgical outcomes of primary tracheal
        tumors remains unclear. This study aimed to characterize the outcomes of neoadjuvant therapy
        for the treatment of primary tracheal squamous cell carcinoma.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Major pathologic response (MPR)
  time frame: up to 4 months
  description: MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
  measure: Safety: frequency of severe adverse events
  time frame: up to 5 months
  description: The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
  measure: Progression-free survival (PFS)
  time frame: up to 24 months
  description: PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1, whichever occurs first.
  measure: Overall survival (OS)
  time frame: up to 60 months
  description: It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
  measure: Disease control rate (DCR)
  time frame: up to 60 months
  description: The proportion of patients whose best overall remission (BOR) is CR, PR or disease stable (SD) according to RECISTv1.1 evaluation
  measure: Duration of remission (DOR)
  time frame: up to 60 months
  description: According to the time from the first recording of objective remission to relapse or death from any cause determined by RECISTv1.1, whichever occurs first.
  measure: R0 rate
  time frame: up to 4 months
  description: There were no visible tumors in the surgical margin, and the tumor cells in the surgical margin within 1mm were negative under the microscope
  arm group label: Nivolumab
  arm group type: Experimental
  description: Neoadjuvant treatment stage: Nivolumab 360mg, Carboplatin AUC5+ paclitaxel 100 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with primary tracheal squamous cell carcinoma received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion.
  intervention type: Drug
  intervention name: Nivolumab Injection [Opdivo]
  description: Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel
  arm group label: Nivolumab
  other name: carboplatin
  other name: paclitaxel
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Shuben Li, PhD
  role: Study Chair
  affiliation: The First Affiliated Hospital of Guangzhou Medical University
  last name: Shuben Li, PhD
  phone: +8613500030280
  email: 13500030280@163.com
  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
  investigator full name: Shuben Li
  investigator title: Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Paclitaxel
  mesh term: Carboplatin
  mesh term: Nivolumab
  sharing ipd: Undecided