<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/NCT03251443</url>
  </required_header>
  <id_info>
    <org_study_id>JS-1392</org_study_id>
    <nct_id>NCT03251443</nct_id>
  </id_info>
  <brief_title>A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma</brief_title>
  <official_title>Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      The purpose of this study is to explore the efficacy and safety of second-line treatment of&#xD;
      apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety,&#xD;
      progression free and overall survival. The primary endpoint of this study is objective&#xD;
      response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">May 8, 2019</completion_date>
  <primary_completion_date type="Actual">March 8, 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 (PFS)</measure>
    <time_frame>six months</time_frame>
    <description>A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>two years</time_frame>
    <description>Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Event</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Intrahepatic Cholangiocarcinoma</condition>
  <condition>Second-line Treatment</condition>
  <arm_group>
    <arm_group_label>Apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.</description>
    <arm_group_label>Apatinib</arm_group_label>
    <other_name>Apatinib mesylate tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma&#xD;
             with stage IV;&#xD;
&#xD;
          -  Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with&#xD;
             first-line treatment;&#xD;
&#xD;
          -  The previous treatment and the present trial registration must be at least 2 weeks&#xD;
             apart, and they must have recovered from any toxicity of a previous treatment;&#xD;
&#xD;
          -  Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST),&#xD;
             version 1.1;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance score (ECOG): 0-2;&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks;&#xD;
&#xD;
          -  Subjects who understand and voluntarily signed a written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous locoregional therapy within 4 weeks prior to enrollment.&#xD;
&#xD;
          -  Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar&#xD;
             hepatocellular carcinoma.&#xD;
&#xD;
          -  History of other malignancy within 5 years except for non-melanoma skin cancer, cervix&#xD;
             in situ carcinoma.&#xD;
&#xD;
          -  Prepared for liver transplantation.&#xD;
&#xD;
          -  Patients with contraindications (active bleeding, ulcers, intestinal perforation,&#xD;
             intestinal obstruction, within 30 days after major surgery, uncontrolled high blood&#xD;
             pressure medication, III-IV level cardiac insufficiency, severe liver and kidney&#xD;
             dysfunction).&#xD;
&#xD;
          -  A previous history of Interstitial pulmonary disease, drug-induced interstitial&#xD;
             disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung&#xD;
             disease with any clinical evidence.&#xD;
&#xD;
          -  Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients with central nervous system metastases or brain metastasis&#xD;
&#xD;
          -  Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or&#xD;
             dementia.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Patients with bone metastasis received palliative radiation within 4 weeks prior to&#xD;
             enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hai-tao Zhao</last_name>
    <role>Study Chair</role>
    <affiliation>Peking Union Medical College Hospital (PUMCH)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</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>Cholangiocarcinoma</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/NCT03251443
org study id: JS-1392
nct id: NCT03251443
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the efficacy and safety of second-line treatment of
      apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety,
      progression free and overall survival. The primary endpoint of this study is objective
      response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free Survival (PFS)
time frame: six months
description: A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
measure: Objective Response Rate (ORR)
time frame: one year
measure: Disease Control Rate (DCR)
time frame: one year
measure: Overall Survival (OS)
time frame: two years
description: Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause
measure: Incidence of Treatment-Emergent Adverse Event
time frame: one year
arm group label: Apatinib
arm group type: Experimental
description: A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
intervention type: Drug
intervention name: Apatinib
description: 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
arm group label: Apatinib
other name: Apatinib mesylate tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hai-tao Zhao
role: Study Chair
affiliation: Peking Union Medical College Hospital (PUMCH)
facility: 
country: China
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Apatinib