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/NCT05965154</url>
    </required_header>
    <id_info>
      <org_study_id>2022-LCYJ-ZF-09</org_study_id>
      <nct_id>NCT05965154</nct_id>
    </id_info>
    <brief_title>Calizumab Combined With Bevacizumab and Capecitabine in the Treatment of Head and Neck Squamous Cell Carcinoma</brief_title>
    <official_title>Carrilizumab Combined With Bevacizumab Plus Capecitabine in a Second-line Prospective, One-arm Exploratory Study of Relapsed Metastatic Squamous Cell Carcinoma of Head and Neck</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, one-arm exploratory second-line study of carrilizumab combined with&#xD;
        bevacizumab plus capecitabine in relapsed metastatic squamous cell carcinoma of the head and&#xD;
        neck.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single-center, single-arm, phase II clinical study. The study was&#xD;
        intended to include histologically or cytologically determined squamous cell carcinoma of the&#xD;
        head and neck, which the investigators assessed as metastatic. After the patients signed&#xD;
        informed consent and met the screening criteria, the second-line patients received&#xD;
        carrilizumab combined with bevacizumab and capecitabine until disease progression,&#xD;
        intolerable toxicity, death, or the subject's decision to withdraw from the study for a&#xD;
        maximum of two years.&#xD;
  &#xD;
        Radiographic evaluations were performed using RECIST v1.1, and baseline evaluations were&#xD;
        conducted within 28 days prior to enrollment. Tumor imaging evaluation was performed every 6&#xD;
        weeks (±3 days) from the first administration of the drug in the study. After reaching CR,&#xD;
        patients entered the maintenance treatment period of carrilizumab. After 48 weeks, tumor&#xD;
        imaging evaluation was performed every 12 weeks (±7 days). Imaging tests before signing the&#xD;
        ICF, if within 28 days before starting treatment, can be used as screening tests.&#xD;
  &#xD;
        During the study, participants will receive safety follow-up from the first dose of&#xD;
        carrilizumab until 30 days after the last dose).&#xD;
  &#xD;
        Experimental drugs: carrilizumab, bevacizumab, capecitabine&#xD;
  &#xD;
        Administration regimen:&#xD;
  &#xD;
          1. Carrilizumab: 200mg/ cycle, three weeks as a treatment cycle, the first day of each&#xD;
             cycle, intravenous drip;&#xD;
  &#xD;
          2. Bevacizumab: 7.5mg/kg, intravenous infusion on the first day of each cycle, every 3&#xD;
             weeks for 1 cycle (Q3W);&#xD;
  &#xD;
          3. Capecitabine: 1250mg/m2, three weeks as a treatment cycle, oral twice a day (once in the&#xD;
             morning and once in the evening; Stop the drug for 1 week after 2 weeks of treatment.&#xD;
  &#xD;
        Duration of test plan and inclusion time:&#xD;
  &#xD;
          1. Program selection time: 22 months.&#xD;
  &#xD;
          2. Duration of the planned study: 24 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</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>Objective response rate</measure>
      <time_frame>From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.</time_frame>
      <description>Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease control rate</measure>
      <time_frame>From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.</time_frame>
      <description>Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival time</measure>
      <time_frame>From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.</time_frame>
      <description>The time between the patient's first treatment date and any recorded tumor progression or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival time</measure>
      <time_frame>From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.</time_frame>
      <description>The time between the patient's date of first treatment and death from any cause.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Head and Neck Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Carrilizumab combined with bevacizumab plus capecitabine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study is a one-arm, exploratory study and does not involve randomization.There was only one trial group of carrilizumab plus bevacizumab plus capecitabine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carrilizumab, bevacizumab,capecitabine</intervention_name>
      <description>Carrilizumab: 200mg/ cycle, three weeks as a treatment cycle, the first day of each cycle, intravenous drip;&#xD;
  Bevacizumab: 7.5mg/kg, intravenous infusion on the first day of each cycle, every 3 weeks for 1 cycle (Q3W);&#xD;
  Capecitabine: 1250mg/m2, three weeks as a treatment cycle, oral twice a day (once in the morning and once in the evening; Stop the drug for 1 week after 2 weeks of treatment.</description>
      <arm_group_label>Carrilizumab combined with bevacizumab plus capecitabine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically or cytologically determined, the investigators assessed patients with&#xD;
               relapsed or metastatic squamous cell carcinoma of the head and neck. Including&#xD;
               nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer,&#xD;
               laryngeal cancer, etc.&#xD;
  &#xD;
            -  The age range is between 18 and 85.&#xD;
  &#xD;
            -  Expected survival &gt; 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with uncured malignancies other than recurrent or metastatic squamous cell&#xD;
               carcinoma of the head and neck diagnosed within 5 years prior to initial&#xD;
               administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous&#xD;
               epithelial carcinoma, and/or carcinoma in situ after radical excision).&#xD;
  &#xD;
            -  Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target&#xD;
               another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40,&#xD;
               CD137).&#xD;
  &#xD;
            -  Known allogeneic organ transplantation (except corneal transplantation) or&#xD;
               allohematopoietic stem cell transplantation.&#xD;
  &#xD;
            -  other.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jingqi Chen, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Principal Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jingqi Chen, MD</last_name>
      <phone>18928787238</phone>
      <email>chenjingqi2002@163.com</email>
    </overall_contact>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Bevacizumab</mesh_term>
      <mesh_term>Capecitabine</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/NCT05965154
  org study id: 2022-LCYJ-ZF-09
  nct id: NCT05965154
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, one-arm exploratory second-line study of carrilizumab combined with
        bevacizumab plus capecitabine in relapsed metastatic squamous cell carcinoma of the head and
        neck.
  This is a prospective, single-center, single-arm, phase II clinical study. The study was
        intended to include histologically or cytologically determined squamous cell carcinoma of the
        head and neck, which the investigators assessed as metastatic. After the patients signed
        informed consent and met the screening criteria, the second-line patients received
        carrilizumab combined with bevacizumab and capecitabine until disease progression,
        intolerable toxicity, death, or the subject's decision to withdraw from the study for a
        maximum of two years.
  
        Radiographic evaluations were performed using RECIST v1.1, and baseline evaluations were
        conducted within 28 days prior to enrollment. Tumor imaging evaluation was performed every 6
        weeks (±3 days) from the first administration of the drug in the study. After reaching CR,
        patients entered the maintenance treatment period of carrilizumab. After 48 weeks, tumor
        imaging evaluation was performed every 12 weeks (±7 days). Imaging tests before signing the
        ICF, if within 28 days before starting treatment, can be used as screening tests.
  
        During the study, participants will receive safety follow-up from the first dose of
        carrilizumab until 30 days after the last dose).
  
        Experimental drugs: carrilizumab, bevacizumab, capecitabine
  
        Administration regimen:
  
          1. Carrilizumab: 200mg/ cycle, three weeks as a treatment cycle, the first day of each
             cycle, intravenous drip;
  
          2. Bevacizumab: 7.5mg/kg, intravenous infusion on the first day of each cycle, every 3
             weeks for 1 cycle (Q3W);
  
          3. Capecitabine: 1250mg/m2, three weeks as a treatment cycle, oral twice a day (once in the
             morning and once in the evening; Stop the drug for 1 week after 2 weeks of treatment.
  
        Duration of test plan and inclusion time:
  
          1. Program selection time: 22 months.
  
          2. Duration of the planned study: 24 months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate
  time frame: From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.
  description: Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients
  measure: Disease control rate
  time frame: From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.
  description: Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.
  measure: Progression-free survival time
  time frame: From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.
  description: The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
  measure: Overall survival time
  time frame: From the time a patient signs the ICF to the last dose, each patient will be followed up until death or withdrawal from the study or until 6 months after the last eligible patient is enrolled.
  description: The time between the patient's date of first treatment and death from any cause.
  arm group label: Carrilizumab combined with bevacizumab plus capecitabine
  arm group type: Experimental
  description: This study is a one-arm, exploratory study and does not involve randomization.There was only one trial group of carrilizumab plus bevacizumab plus capecitabine.
  intervention type: Drug
  intervention name: Carrilizumab, bevacizumab,capecitabine
  description: Carrilizumab: 200mg/ cycle, three weeks as a treatment cycle, the first day of each cycle, intravenous drip;
  Bevacizumab: 7.5mg/kg, intravenous infusion on the first day of each cycle, every 3 weeks for 1 cycle (Q3W);
  Capecitabine: 1250mg/m2, three weeks as a treatment cycle, oral twice a day (once in the morning and once in the evening; Stop the drug for 1 week after 2 weeks of treatment.
  arm group label: Carrilizumab combined with bevacizumab plus capecitabine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Jingqi Chen, MD
  role: Study Chair
  affiliation: Principal Investigator
  last name: Jingqi Chen, MD
  phone: 18928787238
  email: chenjingqi2002@163.com
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Squamous Cell Carcinoma of Head and Neck
  mesh term: Bevacizumab
  mesh term: Capecitabine
  sharing ipd: No