<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/NCT04399785</url>
  </required_header>
  <id_info>
    <org_study_id>CART0326</org_study_id>
    <nct_id>NCT04399785</nct_id>
  </id_info>
  <brief_title>Phase II Study for Combination of Camrelizumab and SBRT in the First-line Treatment for R/M HNSCC</brief_title>
  <official_title>Phase II Study for Combination of Camrelizumab and Stereotacic Radiotherapy in the First-line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xingchen Peng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>West China Hospital</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 study is a prospective, single-center, open-label, phase II clinical study for patients&#xD;
      with recurrent or metastatics quamous cell carcinoma of the head and neck.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Combination of camrelizumab and stereotacic radiotherapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR</measure>
    <time_frame>up to approximately 2 years</time_frame>
    <description>Objective Response Rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>up to approximately 2 years</time_frame>
    <description>Progression-Free-Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>up to approximately 2 years</time_frame>
    <description>OS is the time interval from the start of treatment to death due to any reason or lost of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR</measure>
    <time_frame>up to approximately 2 years</time_frame>
    <description>Disease Control Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>from the first drug administration to within 30 days for the last therapy</time_frame>
    <description>Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Head and Neck Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Camrelizumab and SBRT</intervention_name>
    <description>Camrelizumab: 200mg every 3 weeks; SBRT</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed squamous cell carcinoma of the head and neck;&#xD;
&#xD;
          2. Patients with untreated recurrent or metastatic disease;&#xD;
&#xD;
          3. Combined positive Score&gt;=1;&#xD;
&#xD;
          4. Aged &gt;=18 years;&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;&#xD;
&#xD;
          6. At least one measurable lesion, according to RECIST 1.1;&#xD;
&#xD;
          7. Major organ functions within 28 days prior to treatment meet the following criteria(14&#xD;
             days without transfusion):&#xD;
&#xD;
               1. HB&gt;=80g/L, ANC&gt;=1.5x10^9/L, PLT &gt;=80x10^9/L;&#xD;
&#xD;
               2. TBIL&lt;=1.5 ULN, ALT and AST &lt;=2.5 ULN, if there exists hepatic metastases, ALT and&#xD;
                  AST &lt;=5 ULN, Cr &lt;=1.5 ULN or CCr &gt;=60ml/min;&#xD;
&#xD;
               3. INR or PT &lt;= 1.5 ULN, APTT &lt;=1.5 ULN (if the patient is receiving anticoagulant&#xD;
                  therapy, PT and APTT should be within the expected treatment range);&#xD;
&#xD;
               4. BNP &lt;=ULN;&#xD;
&#xD;
               5. T3 &lt;=ULN and T4 &lt;=ULN after treatment;&#xD;
&#xD;
          8. Appropriate contraception should be used from the start of treatment to 120 days after&#xD;
             the end of treatment; For female subjects with reproductive potential: a negative&#xD;
             serum pregnancy test;&#xD;
&#xD;
          9. Have signed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have other malignant tumors in the past 5 years, except for cured in cured basal cell&#xD;
             carcinoma, situ cervical carcinoma and thyroid papillary carcinoma ;&#xD;
&#xD;
          2. Known allergic reactions to the components of PD-1 monoclonal antibody;&#xD;
&#xD;
          3. Central nervous system metastasis with symptoms;&#xD;
&#xD;
          4. Treatment with a strong CYP3A4 inhibitor within 1 week or a strong inducer of CYP3A4&#xD;
             within 2 weeks.&#xD;
&#xD;
          5. Congestive heart failure of New York Heart Association (NYHA) Class III or IV;&#xD;
&#xD;
          6. Ischemic cardiovascular events occurred within 1 year prior to the start of treatment;&#xD;
&#xD;
          7. ECG QT interval &gt;500ms;&#xD;
&#xD;
          8. Patients are receiving immunosuppressive therapy;&#xD;
&#xD;
          9. Treatment with an immunotherapy, including anti-PD-1, anti-PD-L1 and anti-CTLA-4;&#xD;
&#xD;
         10. Treatment with an investigational agent within 4 weeks;&#xD;
&#xD;
         11. Treatment with oral or parenteral corticosteroids (&gt;10mg per day) within 2 weeks or a&#xD;
             requirement for chronic systemic immunosuppressive therapy;&#xD;
&#xD;
         12. Treatment with anti-tumor vaccine or live vaccines within 4 weeks&#xD;
&#xD;
         13. Surgery or severe trauma within 4 weeks;&#xD;
&#xD;
         14. Active infection;&#xD;
&#xD;
         15. Active autoimmune disease;&#xD;
&#xD;
         16. History of immunodeficiency, including HIV antibody positive, primary&#xD;
             immunodeficiency, or the allogeneic organ transplantation and allogeneic hematopoietic&#xD;
             stem cell transplantation;&#xD;
&#xD;
         17. History of noninfectious pneumonia;&#xD;
&#xD;
         18. Active tuberculosis within 1 year, or had a history of active tuberculosis infection&#xD;
             one year ago but did not receive standard treatment;&#xD;
&#xD;
         19. Active hepatitis, including HBV DNA ≥ 2000IU/ml or 10 ⁴ copies / ml or HCV antibody&#xD;
             and HCV-RNA positive;&#xD;
&#xD;
         20. History of alcoholism and drug abuse;&#xD;
&#xD;
         21. Patients with symptoms of gastrointestinal bleeding or risk of bleeding;&#xD;
&#xD;
         22. Patients are pregnant or breast-feeding;&#xD;
&#xD;
         23. Any other condition or circumstance that could interfere with adherence to the study's&#xD;
             procedures or requirements, or otherwise compromise the study's objectives.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xingchen Peng, Dr</last_name>
    <phone>+86 18980606753</phone>
    <email>pxx2014@scu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yan Li, Dr</last_name>
    <phone>+862885422591</phone>
    <email>yy1240@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xingchen Peng</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xingchen Peng</last_name>
      <phone>+86 18980606753</phone>
      <email>pxx2014@scu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 16, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Xingchen Peng</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Anti-PD-1 Inhibitor</keyword>
  <keyword>Stereotacic Radiotherapy</keyword>
  <keyword>Head and Neck Squamous Cell Carcinoma</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>


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/NCT04399785
org study id: CART0326
nct id: NCT04399785
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, single-center, open-label, phase II clinical study for patients
      with recurrent or metastatics quamous cell carcinoma of the head and neck.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Combination of camrelizumab and stereotacic radiotherapy
primary purpose: Treatment
masking: None (Open Label)
measure: ORR
time frame: up to approximately 2 years
description: Objective Response Rate
measure: PFS
time frame: up to approximately 2 years
description: Progression-Free-Survival
measure: OS
time frame: up to approximately 2 years
description: OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
measure: DOR
time frame: up to approximately 2 years
description: Disease Control Rate
measure: AE
time frame: from the first drug administration to within 30 days for the last therapy
description: Adverse Events
arm group label: Arm 1
arm group type: Experimental
intervention type: Other
intervention name: Camrelizumab and SBRT
description: Camrelizumab: 200mg every 3 weeks; SBRT
arm group label: Arm 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xingchen Peng, Dr
phone: +86 18980606753
email: pxx2014@scu.edu.cn
last name: Yan Li, Dr
phone: +862885422591
email: yy1240@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: West China Hospital
investigator full name: Xingchen Peng
investigator title: Associate professor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck