<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/NCT03030937</url>
  </required_header>
  <id_info>
    <org_study_id>Arise-FJ-G201</org_study_id>
    <nct_id>NCT03030937</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in AGC or EGJA</brief_title>
  <official_title>A Randomized, Parallel Control, Exploratory Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in Subjects With Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Cancer 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 determine whether apatinib plus irinotecan can improve&#xD;
      progression free survival compared with single irinotecan in patients with advanced gastric&#xD;
      cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable&#xD;
      or metastatic disease at the time of diagnosis,so the prognosis is poor.Systemic therapy was&#xD;
      required for the patients with advanced stage. Platinum combined with fluoropyrimidines&#xD;
      always were considered as first line treatment. After failure of initial therapy, single&#xD;
      agent of irinotecan was used as second line treatment,but limited survival benefit.Apatinib,&#xD;
      a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).The purpose of this study is to&#xD;
      determine whether apatinib plus irinotecan can improve progression free survival compared&#xD;
      with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of&#xD;
      esophagogastric junction who failed one lines of chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</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>Randomized</allocation>
    <intervention_model>Parallel 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>18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Event（AE）</measure>
    <time_frame>18 months</time_frame>
    <description>NCI CTC 4.03</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival(OS)</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL)</measure>
    <time_frame>18 months</time_frame>
    <description>Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction</condition>
  <arm_group>
    <arm_group_label>Irinotecan plus apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irinotecan:160mg/m2, ivgtt,given on the eighth day; Apatinib:initial dose:250mg,oral,once a day, after meal ( try to take the medicine at the same time of the dauntoy ).&#xD;
Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irinotecan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Irinotecan:180mg/m2, ivgtt,given on the eighth day. Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).</description>
    <arm_group_label>Irinotecan plus apatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>Irinotecan was used as second line treatment with AGC.</description>
    <arm_group_label>Irinotecan</arm_group_label>
    <arm_group_label>Irinotecan plus apatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age：18~70years;&#xD;
&#xD;
          2. Subjects with Histologically or cytologically confirmed advanced gastric cancer or&#xD;
             adenocarcinoma of esophagogastric junction ；&#xD;
&#xD;
          3. Subjects must have received no more than one lines treatment before participating,and&#xD;
             have received no irinotecan or antiangiogenic（including apatinib）treatment previously;&#xD;
             Note：(1) Time of first-line treatment for subjects with advanced tumour must more than&#xD;
             1 cycles;(2) Adjuvant / neoadjuvant therapy was allowed; adjuvant / neoadjuvant&#xD;
             therapy will be considered as a first-line treatment if disease recurrence during&#xD;
             treatment or after less than 24 weeks.&#xD;
&#xD;
          4. subjects with at least one measurable lesion as defined by RECIST (version&#xD;
             1.1);Lesions previously treated with radiotherapy or locoregional therapy must show&#xD;
             radiographic evidence of disease progression to be deemed a target lesion.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；&#xD;
&#xD;
          6. Survival expectation≥ 3 months;&#xD;
&#xD;
          7. The interval of subjects had received cytotoxic drugs, radiotherapy or surgery must&#xD;
             more than 4 weeks(besides nitroso or mitomycin must more than 6 weeks), and the wound&#xD;
             has healed before participating;&#xD;
&#xD;
          8. No serious concomitant diseases(including heart,lung,liver jaundice or&#xD;
             gastrointestinal obstruction and so on );&#xD;
&#xD;
          9. Adequate organ functions defined as indicated below： （1）Adequate bone marrow function,&#xD;
             defined as: (no blood transfusion within 14 days)&#xD;
&#xD;
               1. Hemoglobin (Hb)≥80g/L，&#xD;
&#xD;
               2. White blood count (WBC)≥3.5×109/L&#xD;
&#xD;
               3. Absolute neutrophil count (ANC)≥1.5×109/L，&#xD;
&#xD;
               4. Platelet count (PLT)≥75×109/L； （2）Adequate liver function, defined as:&#xD;
&#xD;
               1. Bilirubin ≤1.5×the upper limit of normal (ULN)&#xD;
&#xD;
               2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) ≤3.0×(ULN),&#xD;
                  Glutamyl transpeptidase(GGT)≤2.5×(ULN), (When liver metastases, ALT or AST and&#xD;
                  GPT &lt;5.0×(ULN)).&#xD;
&#xD;
               3. serum creatinine ≤1.0×（ULN）, or creatinine clearance &gt; 50 mL/min( calculated per&#xD;
                  the Cockcroft and Gault formula)&#xD;
&#xD;
         10. Females of childbearing potential must be a pregnancy test in 7 days before&#xD;
             participating ( including serum or urine), and the results were negative, Females of&#xD;
             childbearing potential must agree to use a highly effective method of contraception&#xD;
             throughout the entire study period and for 8 weeks after study drug discontinuation.&#xD;
             Male subjects must have had a successful vasectomy or they and their female partners&#xD;
             must meet the criteria above (i.e.not of childbearing potential or practicing highly&#xD;
             effective contraception throughout the study period and for 8 weeks after study drug&#xD;
             discontinuation).&#xD;
&#xD;
         11. Subjects provided written informed consent before participating,Willing and able to&#xD;
             comply with all aspects of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females are lactating or pregnant at Screening or Baseline&#xD;
&#xD;
          2. Subjects with other active malignancy (except for definitively treated melanoma&#xD;
             in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the&#xD;
             cervix)&#xD;
&#xD;
          3. Subjects with symptomatic brain metastases；&#xD;
&#xD;
          4. Subjects with uncontrolled blood pressure with medication (140/90 mmHg),&#xD;
&#xD;
          5. Subjects with coronary heart disease (CHD) above grade I, arrhythmia (including&#xD;
             Prolongation of QTc interval : Male subjects &gt; 450 ms, Females&gt; 470 ms) or cardiac&#xD;
             dysfunction;.&#xD;
&#xD;
          6. Subjects with gastrointestinal bleeding tendency,including the following: current of&#xD;
             local active ulcerative lesions with fstool OB (+ +); history of melena or hematemesis&#xD;
             within past 2 months ; current of fstool OB (+) with gastric primary tumor without&#xD;
             surgical , investigator considerd ulcerative stomach cancer is associated with risks&#xD;
             of gastrointestinal bleeding.&#xD;
&#xD;
          7. Subjects with bleeding tendency ，defined as abnormal coagulation&#xD;
             (INR&gt;1.5×(ULN),APTT&gt;1.5 ×(ULN));&#xD;
&#xD;
          8. Subjects with previous history of cardiovascular and cerebrovascular diseases ,those&#xD;
             receiving thrombolytics or anticoagulants were excluded&#xD;
&#xD;
          9. Subjects with urine protein positive (defined as urine protein detection 2+ or above,&#xD;
             or urine protein ≥ 1 g/24 hours );&#xD;
&#xD;
         10. Subjects with a variety of factors that affect oral medications (such as inability to&#xD;
             swallow, persistent nausea and vomiting, chronic diarrhea and intestinal obstruction,&#xD;
             and so on.);&#xD;
&#xD;
         11. Subject with any other condition that in the opinion of the investigator would&#xD;
             preclude his/her participation in a clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianwei Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianwei Yang</last_name>
    <phone>008613805097959</phone>
    <email>swzcq62@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sha Huang</last_name>
    <phone>008613763820570</phone>
    <email>huangsha0210@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jianwei Yang</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 22, 2017</last_update_submitted>
  <last_update_submitted_qc>January 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 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>Adenocarcinoma</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Apatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03030937
org study id: Arise-FJ-G201
nct id: NCT03030937
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether apatinib plus irinotecan can improve
      progression free survival compared with single irinotecan in patients with advanced gastric
      cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.
Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable
      or metastatic disease at the time of diagnosis,so the prognosis is poor.Systemic therapy was
      required for the patients with advanced stage. Platinum combined with fluoropyrimidines
      always were considered as first line treatment. After failure of initial therapy, single
      agent of irinotecan was used as second line treatment,but limited survival benefit.Apatinib,
      a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).The purpose of this study is to
      determine whether apatinib plus irinotecan can improve progression free survival compared
      with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of
      esophagogastric junction who failed one lines of chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival (PFS)
time frame: 18 months
measure: Adverse Event（AE）
time frame: 18 months
description: NCI CTC 4.03
measure: Objective Response Rate (ORR)
time frame: 18 months
measure: Disease Control Rate (DCR)
time frame: 18 months
measure: Overall Survival(OS)
time frame: 18 months
measure: Quality of Life (QoL)
time frame: 18 months
description: Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].
arm group label: Irinotecan plus apatinib
arm group type: Experimental
description: Irinotecan:160mg/m2, ivgtt,given on the eighth day; Apatinib:initial dose:250mg,oral,once a day, after meal ( try to take the medicine at the same time of the dauntoy ).
Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.
arm group label: Irinotecan
arm group type: Active Comparator
description: Irinotecan:180mg/m2, ivgtt,given on the eighth day. Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.
intervention type: Drug
intervention name: Apatinib
description: Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).
arm group label: Irinotecan plus apatinib
intervention type: Drug
intervention name: Irinotecan
description: Irinotecan was used as second line treatment with AGC.
arm group label: Irinotecan
arm group label: Irinotecan plus apatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jianwei Yang
role: Principal Investigator
affiliation: Fujian Cancer Hospital
last name: Jianwei Yang
phone: 008613805097959
email: swzcq62@163.com
last name: Sha Huang
phone: 008613763820570
email: huangsha0210@163.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Stomach Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Irinotecan
mesh term: Apatinib
sharing ipd: Undecided