<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/NCT03029013</url>
  </required_header>
  <id_info>
    <org_study_id>ACSTCC</org_study_id>
    <nct_id>NCT03029013</nct_id>
  </id_info>
  <brief_title>Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer</brief_title>
  <official_title>A Phase II Clinical Trial Study on Apatinib and Chemotherapy Sequential Treatment With Advanced Metastatic Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Military Medical University</source>
  <brief_summary>
    <textblock>
      The study is the single arm and single center clinical trials，We conduct the phase II&#xD;
      clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy&#xD;
      sequential treatment with advanced recurrence of metastatic cervical cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</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>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib and chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Apatinib， 250 mg qd，po，after 7 days , paclitaxel (135-175 mg/m2) and platinum two drug standard chemotherapy, 21 days as a treatment cycle，during the chemotherapy of 7-21 days continue to offer the Apatinib. without disease progress, after 4 chemotherapy cycles, patients continue to accept the Apatinib maintenance treatment.</description>
    <arm_group_label>experimental group</arm_group_label>
    <other_name>YN968D1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The pathological diagnosis of recurrent or metastatic cervical cancer;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;&#xD;
&#xD;
          -  Life expectancy of more than 3months;&#xD;
&#xD;
          -  With normal marrow, liver and renal function：&#xD;
&#xD;
               -  blood routine examination ：HB≥90g/L，ANC ≥1.5×10*9/L，PLT≥80×10*9/L；&#xD;
&#xD;
               -  Biochemical examination: total bilirubin (TBil) of ≤1.5 upper normal limitation&#xD;
                  (UNL)，alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of ≤2.5&#xD;
                  UNL or ≤5 UNL ，acreatinine (Cr) of ≤ 1.25 UNL; creatinine clearance rate ≥&#xD;
                  45ml/min (Cockcroft-Gault);&#xD;
&#xD;
          -  With written informed consent signed voluntarily by patients themselves .&#xD;
&#xD;
          -  With good compliance and agree to accept follow-up of disease progression and adverse&#xD;
             events.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Suffered from grade II or above myocardial ischemia or myocardial infarction,&#xD;
             uncontrolled arrhythmias&#xD;
&#xD;
          -  With abnormal coagulation function， bleeding tendency or treating with thrombolysis&#xD;
             and anticoagulation&#xD;
&#xD;
          -  History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage,&#xD;
             bleeding ulcer, occult blood ≥ (++), and vasculitis) =&lt; 3 months prior to&#xD;
             randomization;&#xD;
&#xD;
          -  uncured the wound or fracture&#xD;
&#xD;
          -  Centrally located tumors of local invasion of major blood vessels, or Researchers&#xD;
             think that patients may invade the important blood vessels and cause fatal bleeding&#xD;
             (CT or MRI);&#xD;
&#xD;
          -  Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and&#xD;
             intestinal obstruction);&#xD;
&#xD;
          -  Urine protein &gt;++, or urine protein in 24 hours&gt; 1.0g&#xD;
&#xD;
          -  Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac&#xD;
             effusion) requiring treatment&#xD;
&#xD;
          -  History of uncontrolled psychotropic drug abuse or mental disorders;&#xD;
&#xD;
          -  Prior VEGFR inhibitor treatment ;&#xD;
&#xD;
          -  Other malignancy within Before or at the same time other than basal cell skin cancer,&#xD;
             or carcinoma in situ of the cervix;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jin Feng, MD</last_name>
    <phone>86-13908315698</phone>
    <email>wanggedaping@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Daping Hospital, Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Jin, M.D.</last_name>
      <phone>86-13908315698</phone>
      <email>wanggedaping@163.com</email>
    </contact>
    <investigator>
      <last_name>Ge Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Feng Jin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Ge Wang</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</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/NCT03029013
org study id: ACSTCC
nct id: NCT03029013
lead sponsor: 
The study is the single arm and single center clinical trials，We conduct the phase II
      clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy
      sequential treatment with advanced recurrence of metastatic cervical cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
time frame: 24 months
measure: overall survival
time frame: 24 months
arm group label: experimental group
arm group type: Experimental
description: Apatinib and chemotherapy
intervention type: Drug
intervention name: Apatinib
description: Apatinib， 250 mg qd，po，after 7 days , paclitaxel (135-175 mg/m2) and platinum two drug standard chemotherapy, 21 days as a treatment cycle，during the chemotherapy of 7-21 days continue to offer the Apatinib. without disease progress, after 4 chemotherapy cycles, patients continue to accept the Apatinib maintenance treatment.
arm group label: experimental group
other name: YN968D1
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jin Feng, MD
phone: 86-13908315698
email: wanggedaping@163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Military Medical University
investigator full name: Ge Wang
investigator title: M.D.
mesh term: Uterine Cervical Neoplasms
mesh term: Apatinib