<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/NCT03285906</url>
  </required_header>
  <id_info>
    <org_study_id>AHEAD-HBE001</org_study_id>
    <nct_id>NCT03285906</nct_id>
  </id_info>
  <brief_title>An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric</brief_title>
  <official_title>An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and 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 Phase II, Open-label, single arm, exploratory study is to evaluate the&#xD;
      efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal&#xD;
      cancer or esophageal and gastric&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the&#xD;
      clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by&#xD;
      apatinib mesilate.The main research object for first-line treatment failure Ⅲ/Ⅳ integration&#xD;
      of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study&#xD;
      was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction&#xD;
      carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary&#xD;
      research is to evaluate the safety of apatinib for second-line treatment of esophageal and&#xD;
      esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and&#xD;
      explore the relationship between VEGFR-2 high expression and apatinib efficacy and related&#xD;
      prognostic factors. Thirty patients were enrolled in the study group. The group was expected&#xD;
      to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of&#xD;
      data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the&#xD;
      CRF table for details.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>Through study completion, an average of 0.5 year</time_frame>
    <description>Objective Response Rate(ORR):The proportion of patients who have been reduced to a certain amount and maintained a certain amount of time, including the CR + PR case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>median Overall Survival</measure>
    <time_frame>Through study completion, an average of 1.5 year</time_frame>
    <description>median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Esophagus Cancer, Stage III</condition>
  <condition>Esophageal Gastric Cardia Type Metaplasia</condition>
  <condition>Esophagus Cancer, Stage IV</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib：500 mg，po，qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Targeted therapy Apatinib：500 mg，po，qd</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>YN968D1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 and ≤ 75 years of age&#xD;
&#xD;
          -  Have failed for 1 lines of chemotherapy&#xD;
&#xD;
          -  ECOG performance scale 0 - 2.&#xD;
&#xD;
          -  Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L,&#xD;
             platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper&#xD;
             limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum&#xD;
             transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥&#xD;
             50ml/min.&#xD;
&#xD;
          -  Life expectancy of more than 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing therapy related toxicity of prior chemotherapy and/or radiation therapy&#xD;
&#xD;
          -  Intercurrence with one of the following: hypertension, coronary artery disease,&#xD;
             arrhythmia and heart failure&#xD;
&#xD;
          -  Any factors that influence the usage of oral administration&#xD;
&#xD;
          -  The center of the tumor invaded local large blood vessels&#xD;
&#xD;
          -  Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE&#xD;
             class 2) or other parts' hemorrhage (≥ CTCAE class 3).&#xD;
&#xD;
          -  Within 6 months before the first treatment occurs artery / venous thromboembolic&#xD;
             events, such as cerebral vascular accident (including transient ischemic attack), deep&#xD;
             vein thrombosis and pulmonary embolism, etc.&#xD;
&#xD;
          -  Less than 4 weeks from the last clinical trial&#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_official>
    <last_name>Pan Zhanyu, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>86-13752570372</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pan Zhanyu, Master</last_name>
    <phone>86-13752570372</phone>
    <email>liyanwei127@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>LI Yanwei, Master</last_name>
    <phone>86-13920292059</phone>
    <email>liyanwei127@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pan Zhanyu, Master</last_name>
      <phone>86-13752570372</phone>
      <email>liyanwei127@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</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>Esophageal Neoplasms</mesh_term>
    <mesh_term>Metaplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>PFS data of patients in this trial are expected to be Shared</ipd_description>
  </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/NCT03285906
org study id: AHEAD-HBE001
nct id: NCT03285906
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the
      efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal
      cancer or esophageal and gastric
This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the
      clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by
      apatinib mesilate.The main research object for first-line treatment failure Ⅲ/Ⅳ integration
      of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study
      was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction
      carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary
      research is to evaluate the safety of apatinib for second-line treatment of esophageal and
      esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and
      explore the relationship between VEGFR-2 high expression and apatinib efficacy and related
      prognostic factors. Thirty patients were enrolled in the study group. The group was expected
      to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of
      data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the
      CRF table for details.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: progression-free survival
time frame: Through study completion, an average of 1 year
description: No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence.
measure: Objective Response Rate
time frame: Through study completion, an average of 0.5 year
description: Objective Response Rate(ORR):The proportion of patients who have been reduced to a certain amount and maintained a certain amount of time, including the CR + PR case.
measure: median Overall Survival
time frame: Through study completion, an average of 1.5 year
description: median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason.
arm group label: Treatment group
arm group type: Experimental
description: Apatinib：500 mg，po，qd
intervention type: Drug
intervention name: Apatinib
description: Targeted therapy Apatinib：500 mg，po，qd
arm group label: Treatment group
other name: YN968D1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pan Zhanyu, Master
role: Principal Investigator
affiliation: 86-13752570372
last name: Pan Zhanyu, Master
phone: 86-13752570372
email: liyanwei127@hotmail.com
last name: LI Yanwei, Master
phone: 86-13920292059
email: liyanwei127@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Metaplasia
mesh term: Apatinib
sharing ipd: Undecided
ipd description: PFS data of patients in this trial are expected to be Shared