<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/NCT03300765</url>
  </required_header>
  <id_info>
    <org_study_id>HN-Shanghai</org_study_id>
    <nct_id>NCT03300765</nct_id>
  </id_info>
  <brief_title>Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer</brief_title>
  <official_title>Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiayun He, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan 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>
      To determine the efficacy and safety of intensity modulated radiation therapy combined with&#xD;
      apatinib for inoperable or iodine refractory thyroid cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2019</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>Progression Free Survival</measure>
    <time_frame>3-year</time_frame>
    <description>The time from date of randomization until date of first documented disease progression or death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short-term treatment response rate</measure>
    <time_frame>Three months after completion of the therapy</time_frame>
    <description>Number of participants responded to the therapy according to RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3-year</time_frame>
    <description>Overall survival is calculated from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response</measure>
    <time_frame>From the initial treatment to first response, up to 3 years</time_frame>
    <description>Time to first response to the therapy according to RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>From first response to disease progression, up to 3 years</time_frame>
    <description>Time from the first response to the therapy to disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03</measure>
    <time_frame>Time interval from start to 3 months after completion of the therapy</time_frame>
    <description>Incidence of acute and late toxicity</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib with IMRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Apatinib will be used as induction therapy in experimental arm.</description>
    <arm_group_label>Apatinib with IMRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity modulated radiation therapy</intervention_name>
    <description>Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.</description>
    <arm_group_label>Apatinib with IMRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand character and individual consequences of the clinical trial.&#xD;
             Willing to sign the written informed consent; Informed consent must be signed before&#xD;
             the enrollment in the trial;&#xD;
&#xD;
          -  Aged ≥ 18 years old;&#xD;
&#xD;
          -  Pathologically confirmed inoperable or iodine refractory thyroid cancer, or&#xD;
             postoperative residual disease detected by imaging studies, or progression disease&#xD;
             within 12 months before enrollment. (all with measurable disease ≥10mm according to&#xD;
             RECIST 1.1);&#xD;
&#xD;
          -  ECOG0-2;&#xD;
&#xD;
          -  Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N&#xD;
             ≥ 1500/mm^3; PLT ≥ 80,000/mm^3; HB≥90g/L;total bilirubin &lt; 1.25ULN; AST/ALT &lt; 2.5 ULN&#xD;
             or &lt; 5 ULN with metastasis; SCr ≤1ULN; CCR &gt; 50ml/min;&#xD;
&#xD;
          -  The survival period is expected to be greater than 3 months;&#xD;
&#xD;
          -  Willing to accept adequate contraception for patients with childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for&#xD;
             radiosensitization was allowed) or thalidomide and its derivative treatments;&#xD;
&#xD;
          -  Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib&#xD;
             and sorafenib;&#xD;
&#xD;
          -  Allergic to apainib;&#xD;
&#xD;
          -  Uncontrolled high blood pressure and heart disease;&#xD;
&#xD;
          -  Patients with gastrointestinal bleeding risk;&#xD;
&#xD;
          -  Coagulation disorders(INR&gt;1.5×ULNAPTT&gt;1.5×ULN);&#xD;
&#xD;
          -  Uroprotein positive (Uroprotein≥2+ or 24-hour urinary protein quantity &gt;1.0g);&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiayun He, MD,PhD</last_name>
    <phone>+86 13917564793</phone>
    <email>hexiayun1962@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fen Xue, MD</last_name>
    <phone>+86 18505123563</phone>
    <email>xuefen1992@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiayun He, MD,PhD</last_name>
      <phone>+86 13917564793</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xiayun He, MD</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <keyword>Thyroid Cancer</keyword>
  <keyword>Apatinib</keyword>
  <keyword>Intensity modulated radiation therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
  </intervention_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/NCT03300765
org study id: HN-Shanghai
nct id: NCT03300765
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determine the efficacy and safety of intensity modulated radiation therapy combined with
      apatinib for inoperable or iodine refractory thyroid cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 3-year
description: The time from date of randomization until date of first documented disease progression or death from any cause
measure: Short-term treatment response rate
time frame: Three months after completion of the therapy
description: Number of participants responded to the therapy according to RECIST 1.1
measure: Overall survival
time frame: 3-year
description: Overall survival is calculated from randomization to death from any cause.
measure: Time to Response
time frame: From the initial treatment to first response, up to 3 years
description: Time to first response to the therapy according to RECIST 1.1
measure: Duration of Response
time frame: From first response to disease progression, up to 3 years
description: Time from the first response to the therapy to disease progression
measure: Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
time frame: Time interval from start to 3 months after completion of the therapy
description: Incidence of acute and late toxicity
arm group label: Apatinib with IMRT
arm group type: Experimental
description: Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F)
intervention type: Drug
intervention name: Apatinib
description: Apatinib will be used as induction therapy in experimental arm.
arm group label: Apatinib with IMRT
intervention type: Radiation
intervention name: Intensity modulated radiation therapy
description: Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.
arm group label: Apatinib with IMRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiayun He, MD,PhD
phone: +86 13917564793
email: hexiayun1962@163.com
last name: Fen Xue, MD
phone: +86 18505123563
email: xuefen1992@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Fudan University
investigator full name: Xiayun He, MD
investigator title: Chief Physician
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
mesh term: Apatinib