<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/NCT04405154</url>
  </required_header>
  <id_info>
    <org_study_id>HP18-TCR-XN001</org_study_id>
    <nct_id>NCT04405154</nct_id>
  </id_info>
  <brief_title>A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer</brief_title>
  <official_title>A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</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>
      The goal of this study is to determine the efficacy and safety of camrelizumab given&#xD;
      concomitantly with chemoradiation in participants with unresectable, locally advanced head&#xD;
      and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in&#xD;
      addition to chemoradiation, the standard treatment for LA-HNSCC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</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>6 months</time_frame>
    <description>The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>OS is the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival (DFS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>DFS is the time from the date of randomization to the date of first record of disease recurrence or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Adverse Events (AEs)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>Investigational Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses.</description>
    <arm_group_label>Investigational Arm</arm_group_label>
    <other_name>SHR-1210</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>75-100 mg/m^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation.</description>
    <arm_group_label>Investigational Arm</arm_group_label>
    <other_name>Platinol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT or VMAT</intervention_name>
    <description>66-70 Gy given in 33-35 fractions over 6-7 weeks.</description>
    <arm_group_label>Investigational Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Has a pathologically proven new diagnosis of head and neck squamous cell carcinoma&#xD;
&#xD;
          -  Has unresectable disease and is eligible for definitive chemoradiation based on&#xD;
             investigator decision&#xD;
&#xD;
          -  Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          -  Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on&#xD;
             RECIST version 1.1&#xD;
&#xD;
          -  Has adequate organ function as defined&#xD;
&#xD;
          -  Female participants of childbearing potential must have a negative urine or serum&#xD;
             pregnancy test within 72 hours prior to receiving the first dose of study therapy&#xD;
&#xD;
          -  Female and male participants of reproductive potential must agree to use adequate&#xD;
             contraception throughout the study period and for up to 180 days after the last dose&#xD;
             of study therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as&#xD;
             nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer&#xD;
&#xD;
          -  Is currently participating or has participated in a study with an investigational&#xD;
             agent or using an investigational device within 4 weeks of the first dose of study&#xD;
             therapy&#xD;
&#xD;
          -  Has history of a diagnosed and/or treated hematologic or primary solid tumor&#xD;
             malignancy, unless in remission for at least 5 years prior to randomization&#xD;
&#xD;
          -  Has a history of severe hypersensitivity reaction to camrelizumab, Cisplatin or&#xD;
             radiotherapy&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any&#xD;
             other form of immunosuppressive therapy within 7 days prior to the first dose of study&#xD;
             therapy&#xD;
&#xD;
          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or&#xD;
             anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or has previously&#xD;
             participated in clinical studies with camrelizumab&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to the first dose of study therapy&#xD;
&#xD;
          -  Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical&#xD;
             surgery for head and neck cancer under study&#xD;
&#xD;
          -  Has not recovered from major surgery prior to starting study therapy&#xD;
&#xD;
          -  Has known active Hepatitis B or C&#xD;
&#xD;
          -  Has known history of Human Immunodeficiency Virus (HIV)&#xD;
&#xD;
          -  Has a significant cardiovascular disease&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in the past 2&#xD;
             years. Replacement therapy is not considered a form of systemic treatment&#xD;
&#xD;
          -  Has had previous allogeneic tissue/solid organ transplant&#xD;
&#xD;
          -  Has active infection requiring systemic therapy&#xD;
&#xD;
          -  Is pregnant or breast feeding&#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>Yan Li, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Li, MD, PhD</last_name>
    <phone>18980606806</phone>
    <email>yy1240@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xingchen Peng, MD,PhD</last_name>
    <phone>18980606753</phone>
    <email>pxx2014@scu.edu.cn</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Yan Li</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Head and Neck</keyword>
  <keyword>Squamous Cell Carcinoma</keyword>
  <keyword>Immune Checkpoint Inhibitors</keyword>
  <keyword>Chemoradiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04405154
org study id: HP18-TCR-XN001
nct id: NCT04405154
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to determine the efficacy and safety of camrelizumab given
      concomitantly with chemoradiation in participants with unresectable, locally advanced head
      and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in
      addition to chemoradiation, the standard treatment for LA-HNSCC.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate
time frame: 6 months
description: The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
measure: Overall Survival (OS)
time frame: Up to 5 years
description: OS is the time from randomization to death due to any cause.
measure: Disease-free Survival (DFS)
time frame: Up to 5 years
description: DFS is the time from the date of randomization to the date of first record of disease recurrence or death.
measure: Acute Adverse Events (AEs)
time frame: Up to 6 months
description: The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
arm group label: Investigational Arm
arm group type: Experimental
description: Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.
intervention type: Biological
intervention name: Camrelizumab
description: Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses.
arm group label: Investigational Arm
other name: SHR-1210
intervention type: Drug
intervention name: Cisplatin
description: 75-100 mg/m^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation.
arm group label: Investigational Arm
other name: Platinol
intervention type: Radiation
intervention name: IMRT or VMAT
description: 66-70 Gy given in 33-35 fractions over 6-7 weeks.
arm group label: Investigational Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yan Li, MD,PhD
role: Principal Investigator
affiliation: West China Hospital
last name: Yan Li, MD, PhD
phone: 18980606806
email: yy1240@163.com
last name: Xingchen Peng, MD,PhD
phone: 18980606753
email: pxx2014@scu.edu.cn
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Yan Li
investigator title: MD, PhD
mesh term: Head and Neck Neoplasms
mesh term: Cisplatin
sharing ipd: No