<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/NCT04440917</url>
  </required_header>
  <id_info>
    <org_study_id>2020HNRT01</org_study_id>
    <nct_id>NCT04440917</nct_id>
  </id_info>
  <brief_title>Camrelizumab Combined With Apatinib Mesylate for Head and Neck Squamous Cell Carcinoma</brief_title>
  <acronym>IMplus</acronym>
  <official_title>Induction Therapy of Camrelizumab Combined With Apatinib Mesylate for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (the IMplus Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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, open-labelled study to evaluate the efficacy and safety of&#xD;
      camrelizumab combined with apatinib mesylate in the induction treatment of patients with&#xD;
      locally advanced head and neck squamous cell carcinoma who were judged surgically&#xD;
      unresectable or appropriate for non-surgical definitive therapy. The objective response rate&#xD;
      (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS)&#xD;
      rate and progression free survival (PFS) rate will be the second endpoints.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2022</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 (CR+PR)</measure>
    <time_frame>9 weeks</time_frame>
    <description>Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Grade 3-4 Toxicity</measure>
    <time_frame>9 weeks</time_frame>
    <description>Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Head and Neck Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inductive therapy with Camrelizumab and Apatinib</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>200mg, iv, on day 1, 15, 29, 43</description>
    <arm_group_label>Study group</arm_group_label>
    <other_name>Humanized anti-PD-1 inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib Mesylate</intervention_name>
    <description>250 mg po, qd, 28 days as a cycle, 2 cycles in total</description>
    <arm_group_label>Study group</arm_group_label>
    <other_name>VEGFR inhibitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed squamous cell or poorly differentiated or&#xD;
             undifferentiated cancer of the head and neck (the primary sites include oral cavity,&#xD;
             oropharynx, hypopharynx, larynx, nasal cavity and sinuses);&#xD;
&#xD;
          2. Clinical stage of III-IVb (AJCC 2018);&#xD;
&#xD;
          3. Surgically unresectable and/or refuse surgery or appropriate for non-surgical&#xD;
             definitive therapy;&#xD;
&#xD;
          4. Measurable disease;&#xD;
&#xD;
          5. Eastern cooperative oncology group performance status (ECOG PS) score: 0-1;&#xD;
&#xD;
          6. Blood routine: white blood cells&gt; 3,000/mm3, hemoglobin&gt; 8g/L, platelets&gt;&#xD;
             80,000/mm3；Liver function: Alanine Transaminase/Aspartate Transaminase &lt;2.5 times the&#xD;
             upper limit of normal, bilirubin &lt;1.5 times the upper limit of normal; Renal function:&#xD;
             serum creatinine &lt;1.5 times the upper limit of normal;&#xD;
&#xD;
          7. Sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg&#xD;
             and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;&#xD;
&#xD;
          2. Suffered from grade II or above myocardial ischemia or myocardial infarction,&#xD;
             uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade&#xD;
             III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria&#xD;
             or echocardiography check: left ventricular ejection fraction (LVEF)&lt;50%;&#xD;
&#xD;
          3. Has had another active malignancy within the past five years except for cervical&#xD;
             cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the&#xD;
             skin;&#xD;
&#xD;
          4. Clinically significant and uncontrolled major medical conditions including but not&#xD;
             limited to: active uncontrolled infection, symptomatic congestive heart failure,&#xD;
             Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation&#xD;
             that would limit compliance with study requirements; any medical condition, which in&#xD;
             the opinion of the study investigator places the subject at an unacceptably high risk&#xD;
             for toxicities;&#xD;
&#xD;
          5. Patients undergoing therapy with other investigational agents;&#xD;
&#xD;
          6. Women who are pregnant or breastfeeding;&#xD;
&#xD;
          7. Patients with any other concurrent disease which, in the judgment of the investigator,&#xD;
             would make the patient inappropriate for participation in the study.&#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_contact>
    <last_name>Guopei Zhu, M.D.</last_name>
    <phone>021-23271699</phone>
    <phone_ext>5665</phone_ext>
    <email>antica@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lulu Ye, Master</last_name>
      <phone>021-23271699</phone>
      <phone_ext>5665</phone_ext>
      <email>yee166@163.com</email>
    </contact>
    <investigator>
      <last_name>Guopei Zhu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>January 31, 2021</last_update_submitted>
  <last_update_submitted_qc>January 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</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>Apatinib</mesh_term>
    <mesh_term>Immune Checkpoint Inhibitors</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/NCT04440917
org study id: 2020HNRT01
nct id: NCT04440917
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, open-labelled study to evaluate the efficacy and safety of
      camrelizumab combined with apatinib mesylate in the induction treatment of patients with
      locally advanced head and neck squamous cell carcinoma who were judged surgically
      unresectable or appropriate for non-surgical definitive therapy. The objective response rate
      (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS)
      rate and progression free survival (PFS) rate will be the second endpoints.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (CR+PR)
time frame: 9 weeks
description: Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
measure: Number of Participants With at Least One Grade 3-4 Toxicity
time frame: 9 weeks
description: Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
measure: Overall Survival
time frame: 2 years
description: Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months
measure: Progression-Free Survival
time frame: 2 years
description: Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months
arm group label: Study group
arm group type: Experimental
description: Inductive therapy with Camrelizumab and Apatinib
intervention type: Drug
intervention name: Camrelizumab
description: 200mg, iv, on day 1, 15, 29, 43
arm group label: Study group
other name: Humanized anti-PD-1 inhibitor
intervention type: Drug
intervention name: Apatinib Mesylate
description: 250 mg po, qd, 28 days as a cycle, 2 cycles in total
arm group label: Study group
other name: VEGFR inhibitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Guopei Zhu, M.D.
phone: 021-23271699
phone ext: 5665
email: antica@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Apatinib
mesh term: Immune Checkpoint Inhibitors
sharing ipd: No