<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/NCT03267121</url>
  </required_header>
  <id_info>
    <org_study_id>2017HNRT002</org_study_id>
    <nct_id>NCT03267121</nct_id>
  </id_info>
  <brief_title>A Study of Apatinib and Tegafur Gimeracil Oteracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck</brief_title>
  <official_title>A Non-randomized Phase II Study of Apatinib and Tegafur Gimeracil Oteracil Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of Head and Neck</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>
    <has_dmc>Yes</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 is a non-randomized, phase II, open label study of apatinib mesylate tablets plus&#xD;
      tegafur gimeracil oteracil potassium capsules induction chemotherapy in locally advanced&#xD;
      squamous cell carcinoma of head and neck patients who were judged surgically unresectable or&#xD;
      appropriate for non-surgical definitive therapy.The primary purpose of this study is to&#xD;
      evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium&#xD;
      capsules in locally advanced squamous cell carcinoma of head and neck&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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 chemotherapy 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>Progression Free Survival</measure>
    <time_frame>3 years</time_frame>
    <description>Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
    <description>Rate of Progression Free Survival (Time to death post induction chemotherapy and chemoradiotherapy)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</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>Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib Mesylate Tablets</intervention_name>
    <description>500 mg qd.p.o. every day for 21 days as a cycle</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>Aitan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tegafur Gimeracil Oteracil Potassium Capsules</intervention_name>
    <description>25mg/㎡ bid p.o. every day for 14 days as a cycle</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>Aiyi</other_name>
    <other_name>S-1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed SCCHN or poorly differentiated or&#xD;
             undifferentiated cancer of the head and neck.&#xD;
&#xD;
          2. Measurable disease.&#xD;
&#xD;
          3. All primary sites are eligible excluding nasopharyngeal.&#xD;
&#xD;
          4. Surgically unresectable and/or refuse surgery; Note: surgical unresectability will be&#xD;
             defined as the combination of the treating surgeon's judgment of unresectability plus&#xD;
             one of the following objective criteria:&#xD;
&#xD;
             Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid&#xD;
             artery.&#xD;
&#xD;
             Involvement of prevertebral musculature Invasion of the bone of the skull base Need&#xD;
             for glossectomy or extensive glossal resection where functional outcome is considered&#xD;
             unacceptable to surgeon or patient Involvement of the cervical spine Severe,&#xD;
             unacceptable functional deficit that would result from any proposed definitive&#xD;
             surgical resection.&#xD;
&#xD;
          5. ECOG performance status 0-1&#xD;
&#xD;
          6. Age &gt; or = 18 years. Men and women are eligible for participation.&#xD;
&#xD;
          7. Must have acceptable organ and marrow function as defined below. Laboratory tests&#xD;
             should be completed within 14 days prior to registration:&#xD;
&#xD;
             Absolute Neutrophil Count (ANC) &gt; or = 1,500/mm3 Platelets &gt; or = 100,000/mm3&#xD;
             Hemoglobin (Hgb) &gt; 9g/dL Total bilirubin &lt; or = 1.5mg/dL Albumin &gt; 2.5 g/dL Aspartate&#xD;
             aminotransferase (AST)/Alanine Aminotransferase (ALT) &lt; or = 2.5 times institutional&#xD;
             upper limit of normal, alkaline phosphatase &lt; 2.5 x upper limit of normal, glomerular&#xD;
             filtration rate (GFR) &gt; 30 mL/min (by standard Cockcroft and Gault formula or measured&#xD;
             via 24 hour urine collection)&#xD;
&#xD;
          8. Patients must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document.&#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. Patients who have had prior allergic reaction to Apatinib and Tegafur Gimeracil&#xD;
             Oteracil;&#xD;
&#xD;
          4. The subject has had another active malignancy within the past five years except for&#xD;
             cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of&#xD;
             the skin;&#xD;
&#xD;
          5. 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;
          6. Patients undergoing therapy with other investigational agents.&#xD;
&#xD;
          7. Women who are pregnant or breastfeeding;&#xD;
&#xD;
          8. 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>
  <location>
    <facility>
      <name>Shanghai ninth people's hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Guopei Zhu</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>head and neck cancer</keyword>
  <keyword>Apatinib</keyword>
  <keyword>Tegafur Gimeracil Oteracil</keyword>
  <keyword>induction chemotherapy</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>Apatinib</mesh_term>
    <mesh_term>Tegafur</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03267121
org study id: 2017HNRT002
nct id: NCT03267121
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus
      tegafur gimeracil oteracil potassium capsules induction chemotherapy in locally advanced
      squamous cell carcinoma of head and neck patients who were judged surgically unresectable or
      appropriate for non-surgical definitive therapy.The primary purpose of this study is to
      evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium
      capsules in locally advanced squamous cell carcinoma of head and neck
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 chemotherapy 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: Progression Free Survival
time frame: 3 years
description: Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy)
measure: Overall Survival
time frame: 3 years
description: Rate of Progression Free Survival (Time to death post induction chemotherapy and chemoradiotherapy)
arm group label: Study Group
arm group type: Experimental
description: Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment
intervention type: Drug
intervention name: Apatinib Mesylate Tablets
description: 500 mg qd.p.o. every day for 21 days as a cycle
arm group label: Study Group
other name: Aitan
intervention type: Drug
intervention name: Tegafur Gimeracil Oteracil Potassium Capsules
description: 25mg/㎡ bid p.o. every day for 14 days as a cycle
arm group label: Study Group
other name: Aiyi
other name: S-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Guopei Zhu
investigator title: M.D.
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Apatinib
mesh term: Tegafur
sharing ipd: Undecided