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/NCT06023875</url>
    </required_header>
    <id_info>
      <org_study_id>2023-FXY-011-HNC</org_study_id>
      <nct_id>NCT06023875</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Cadonilimab in Combination With Cisplatin and Nab-paclitaxel in Resectable Head and Neck Squamous Cell Carcinoma</brief_title>
    <acronym>NCCCNRHNSCC</acronym>
    <official_title>An Open, Single-center, Phase II Trial of Cadonilimab Combined With Platinum-containing Dual-agent Neoadjuvant Therapy for Locally Advanced Operable Head and Neck Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xuekui Liu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen 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 study is a single arm phase ll trial including 30 patients with T2N2-3M0、T3-4N0-3M0&#xD;
        (lll-V) head and neck squamous cell carcinoma (HNSCC) eligible forresection, who receive&#xD;
        neo-adjvuant Cadonilimab combined with cisplatin and Nab.paclitaxel.This proposed study will&#xD;
        evaluate the efficacy and safety of preoperativeadministration of Cadonilimab combined with&#xD;
        chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo&#xD;
        surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, eligible subject will be enrolled into study arm to accept study treatment&#xD;
        objective response rate will be the primary outcome measures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 19, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>ORR</measure>
      <time_frame>9 weeks</time_frame>
      <description>overall response rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PCR</measure>
      <time_frame>9 weeks</time_frame>
      <description>Pathological Complete Response</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MPR</measure>
      <time_frame>9 weeks</time_frame>
      <description>Major Pathological Response</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DCR</measure>
      <time_frame>2 years</time_frame>
      <description>Disease Control Rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS</measure>
      <time_frame>2 years</time_frame>
      <description>progression-free survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>5 years</time_frame>
      <description>Overall survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events Graded By Ctcae V5.0</measure>
      <time_frame>90 days after the first dose of study treatment</time_frame>
      <description>Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Head and Neck Squamous Cell Carcinoma</condition>
    <condition>Locally Advanced Operable</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with locally advanced operable head and neck squamous cell carcinoma</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cadonilimab</intervention_name>
      <description>Cadonilimab 10mg/kg. The drug was administered every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.</description>
      <arm_group_label>Experimental group</arm_group_label>
      <other_name>AK104</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Docetaxel</intervention_name>
      <description>Docetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Cisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Newly diagnosed primary head and neck squamous cell carcinoma confirmed by histology&#xD;
               and/or cytology (excluding diagnostic therapy).&#xD;
  &#xD;
            2. Clinical stage: T2N2-3M0, T3-4N0-3M0 (III-IV) (AJCC 8th edition staging).&#xD;
  &#xD;
            3. Age: 18 to 70 years.&#xD;
  &#xD;
            4. PS score (see Appendix Table 1; performance status score of 0 or 1).&#xD;
  &#xD;
            5. Patients evaluated by a head and neck oncologist as resectable with no distant&#xD;
               metastases.&#xD;
  &#xD;
            6. Patients with at least one measurable lesion according to RECIST version 1.1 criteria.&#xD;
  &#xD;
            7. Patients' toxicities assessed according to CTCAE version 4.03 criteria.&#xD;
  &#xD;
            8. Patients with normal organ function (heart, brain, lungs, kidneys) and suitable for&#xD;
               surgery:&#xD;
  &#xD;
                 1. Hematology: White blood cells ≥ 4000/μL, neutrophils ≥ 2,000/μL, hemoglobin ≥ 9&#xD;
                    g/dL, platelets ≥ 100,000/μL;&#xD;
  &#xD;
                 2. Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients&#xD;
                    with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN can be&#xD;
                    included), AST and ALT ≤ 3 times ULN, alkaline phosphatase ≤ 3 times ULN; albumin&#xD;
                    ≥ 3 g/dL;&#xD;
  &#xD;
                 3. Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60&#xD;
                    mL/min according to Cockcroft-Gault formula.&#xD;
  &#xD;
            9. Consent to provide archived tumor tissue samples or undergo biopsy for collection of&#xD;
               tumor lesion tissue (at least 3 unstained FFPE pathological slides, if deemed&#xD;
               insufficient for PD-L1 IHC testing by the central laboratory, an additional 3&#xD;
               unstained FFPE pathological slides should be provided) to be sent to the central&#xD;
               laboratory for PD-L1 immunohistochemistry (IHC) testing (preferably using recently&#xD;
               obtained tumor tissue samples). Tumor lesions planned for biopsy should not be used&#xD;
               for assessing target lesions of the disease unless no other suitable lesions for&#xD;
               biopsy are available. Patients have signed an informed consent form, are willing and&#xD;
               able to comply with the study's visit, treatment plan, laboratory tests, and other&#xD;
               study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of severe hypersensitivity reactions to components of other monoclonal&#xD;
               antibodies, CTLA4, or PD-1 antibodies.&#xD;
  &#xD;
            2. Patients with known or suspected autoimmune diseases, including dementia and epileptic&#xD;
               seizures.&#xD;
  &#xD;
            3. Recurrence, distant metastasis, or the inability to undergo surgery as assessed by a&#xD;
               head and neck physician.&#xD;
  &#xD;
            4. Abnormal coagulation function: (PT &gt; 16s, APTT &gt; 53s, TT &gt; 21s, Fib &lt; 1.5g/L),&#xD;
               bleeding tendency, or currently on anticoagulant or thrombolytic therapy.&#xD;
  &#xD;
            5. Severe heart disease, pulmonary dysfunction, patients with heart or lung function&#xD;
               below Grade 3 (including Grade 3).&#xD;
  &#xD;
            6. Laboratory values not meeting relevant criteria within 7 days prior to enrollment.&#xD;
  &#xD;
            7. Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or&#xD;
               anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulation or&#xD;
               checkpoint pathways).&#xD;
  &#xD;
            8. Pre-existing conditions requiring long-term use of immunosuppressive drugs or a need&#xD;
               for systemic or local use of corticosteroids at immunosuppressive doses prior to&#xD;
               enrollment.&#xD;
  &#xD;
            9. HIV-positive individuals; HBsAg-positive individuals with positive HBV DNA copy number&#xD;
               (quantitative test ≥ 1000 cps/ml); positive chronic hepatitis C blood screening (HCV&#xD;
               antibody positive).&#xD;
  &#xD;
           10. Traditional herbal medicine used for anti-tumor purposes within 4 weeks before&#xD;
               randomization.&#xD;
  &#xD;
           11. Active or prior history of documented inflammatory bowel disease (such as Crohn's&#xD;
               disease, ulcerative colitis, or chronic diarrhea).&#xD;
  &#xD;
           12. Women of childbearing potential with a positive pregnancy test and breastfeeding&#xD;
               women.&#xD;
  &#xD;
           13. Known active pulmonary tuberculosis (TB). Subjects suspected of having active TB need&#xD;
               clinical evaluation for exclusion.&#xD;
  &#xD;
           14. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem&#xD;
               cell transplantation.&#xD;
  &#xD;
           15. Severe infection occurring within 4 weeks before the first administration, including&#xD;
               but not limited to complications requiring hospitalization, sepsis, or severe&#xD;
               pneumonia.&#xD;
  &#xD;
           16. Subjects planning major surgery within 30 days after the first dose of AK104 in&#xD;
               combination with platinum-containing dual-agent therapy (as determined by the&#xD;
               investigator), or not yet fully recovered from prior surgery. Local surgical&#xD;
               procedures (such as placement of a systemic port and prostate biopsy) are allowed&#xD;
               provided that the surgery is completed at least 24 hours before the first dose of the&#xD;
               study treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xuekui Liu</last_name>
      <phone>+8613609713406</phone>
      <email>liuxk@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Center, 651 Dongfeng East Road</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaoyun Feng</last_name>
        <phone>+8615900033919</phone>
        <email>1056608539@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Center, 651 Dongfeng East Road</name>
        <address>
          <city>Guangzhou</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Xuekui Liu</investigator_full_name>
      <investigator_title>chief physician</investigator_title>
    </responsible_party>
    <keyword>head and neck squamous cell carcinoma</keyword>
    <keyword>Cadonilimab</keyword>
    <keyword>neoadjuvant therapy</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Docetaxel</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06023875
  org study id: 2023-FXY-011-HNC
  nct id: NCT06023875
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a single arm phase ll trial including 30 patients with T2N2-3M0、T3-4N0-3M0
        (lll-V) head and neck squamous cell carcinoma (HNSCC) eligible forresection, who receive
        neo-adjvuant Cadonilimab combined with cisplatin and Nab.paclitaxel.This proposed study will
        evaluate the efficacy and safety of preoperativeadministration of Cadonilimab combined with
        chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo
        surgery.
  In this study, eligible subject will be enrolled into study arm to accept study treatment
        objective response rate will be the primary outcome measures.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: ORR
  time frame: 9 weeks
  description: overall response rate
  measure: PCR
  time frame: 9 weeks
  description: Pathological Complete Response
  measure: MPR
  time frame: 9 weeks
  description: Major Pathological Response
  measure: DCR
  time frame: 2 years
  description: Disease Control Rate
  measure: PFS
  time frame: 2 years
  description: progression-free survival
  measure: OS
  time frame: 5 years
  description: Overall survival
  measure: Adverse Events Graded By Ctcae V5.0
  time frame: 90 days after the first dose of study treatment
  description: Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).
  arm group label: Experimental group
  arm group type: Experimental
  description: Patients with locally advanced operable head and neck squamous cell carcinoma
  intervention type: Drug
  intervention name: Cadonilimab
  description: Cadonilimab 10mg/kg. The drug was administered every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.
  arm group label: Experimental group
  other name: AK104
  intervention type: Drug
  intervention name: Docetaxel
  description: Docetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.
  arm group label: Experimental group
  intervention type: Drug
  intervention name: Cisplatin
  description: Cisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Xuekui Liu
  phone: +8613609713406
  email: liuxk@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Xuekui Liu
  investigator title: chief physician
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Squamous Cell Carcinoma of Head and Neck
  mesh term: Docetaxel
  sharing ipd: No