<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/NCT03271073</url>
  </required_header>
  <id_info>
    <org_study_id>AHEAD-Y001</org_study_id>
    <nct_id>NCT03271073</nct_id>
  </id_info>
  <brief_title>A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer</brief_title>
  <official_title>A Exploratory Study of Apatinib in Combination With S1 in Patients With Advanced Gastric Evaluating the Efficacy and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <brief_summary>
    <textblock>
      Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good&#xD;
      safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial&#xD;
      to investigate the safety and efficacy of apatinib combined with S1 after failure of&#xD;
      first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Anticipated">January 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2018</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>Approximately 1 year</time_frame>
    <description>defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>defined as the time from randomize to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety (incidence of adverse events)</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>incidence of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life(QoL)</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib plus S1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle</description>
    <arm_group_label>Apatinib plus S1</arm_group_label>
    <other_name>S1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients, aged between 18 and 75 years old;&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;&#xD;
&#xD;
          3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)&#xD;
             , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or&#xD;
             nonmeasurable evaluable lesions per RECIST 1.1;&#xD;
&#xD;
          4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;&#xD;
&#xD;
          5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets&#xD;
             ≥ 100 × 10*9/L, neutrophil ≥1.5 × 10*9/L, total bilirubin ≤1.5 ×ULN, and serum&#xD;
             transaminase≤2.5×ULN);&#xD;
&#xD;
          6. Expected survival of ≥ 12 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with poor-controlled arterial hypertension (systolic blood pressure&gt; 140 mmHg&#xD;
             and diastolic blood pressure &gt; 90 mm Hg) despite standard medical management; Coronary&#xD;
             heart disease greater than ClassI; I-level arrhythmia (including QT interval&#xD;
             prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac&#xD;
             dysfunction;&#xD;
&#xD;
          2. Subjects with high gastrointestinal bleeding risk, including the following conditions:&#xD;
             local active ulcer lesions with positive fecal occult blood test (++); history of&#xD;
             black stool, or vomiting blood in the past 2 months;&#xD;
&#xD;
          3. Abnormal Coagulation (INR&gt;1.5、APTT&gt;1.5 UNL), with tendency of bleed;&#xD;
&#xD;
          4. Factors that could have an effect on oral medication (such as inability to swallow,&#xD;
             chronic diarrhea and intestinal obstruction);&#xD;
&#xD;
          5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);&#xD;
&#xD;
          6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;&#xD;
&#xD;
          7. Associated with CNS (central nervous system) metastases;&#xD;
&#xD;
          8. Active bacterial infections;&#xD;
&#xD;
          9. Pregnant or breast-feeding women;&#xD;
&#xD;
         10. Any other condition that might place the patient at undue risk or preclude a patient&#xD;
             from completing 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>
  <overall_official>
    <last_name>Wei Deng, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Deng, M.D.</last_name>
    <phone>+8613426136152</phone>
    <email>dengweiwei@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhigang Bai, M.D.</last_name>
    <phone>+8613126617140</phone>
    <email>bai_zhg@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Deng, M.D.</last_name>
      <phone>+8613426136152</phone>
      <email>dengweiwei@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhigang Bai, M.D.</last_name>
      <phone>+8613126617140</phone>
      <email>bai_zhg@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Zhongtao Zhang</investigator_full_name>
    <investigator_title>assistant dean, professor</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>gastroesophageal junction cancer</keyword>
  <keyword>Apatinib</keyword>
  <keyword>S1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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>
  <patient_data>
    <sharing_ipd>No</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/NCT03271073
org study id: AHEAD-Y001
nct id: NCT03271073
lead sponsor: 
Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good
      safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial
      to investigate the safety and efficacy of apatinib combined with S1 after failure of
      first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma
      patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS)
time frame: Approximately 1 year
description: defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy
measure: Overall survival (OS)
time frame: Approximately 2 years
description: defined as the time from randomize to death
measure: Safety (incidence of adverse events)
time frame: Approximately 1 year
description: incidence of adverse events
measure: Quality of life(QoL)
time frame: Approximately 2 years
description: as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
arm group label: Apatinib plus S1
arm group type: Experimental
description: patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity
intervention type: Drug
intervention name: Apatinib
description: Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle
arm group label: Apatinib plus S1
other name: S1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wei Deng, M.D.
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Wei Deng, M.D.
phone: +8613426136152
email: dengweiwei@126.com
last name: Zhigang Bai, M.D.
phone: +8613126617140
email: bai_zhg@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Zhongtao Zhang
investigator title: assistant dean, professor
mesh term: Stomach Neoplasms
mesh term: Apatinib
sharing ipd: No