<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/NCT03788174</url>
  </required_header>
  <id_info>
    <org_study_id>FNF013</org_study_id>
    <nct_id>NCT03788174</nct_id>
  </id_info>
  <brief_title>Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma</brief_title>
  <official_title>Phase II Study on the Second-line Treatment of Gastric Adenocarcinoma With Apatinib Combined With POF(Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)</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>
      In previous studies,the investigators found that POF (A combination of oxaliplatin,&#xD;
      fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in&#xD;
      patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was&#xD;
      approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced&#xD;
      gastric cancer. Therefore, investigators conducted the dose escalation phase I study to&#xD;
      explore the safety of combination of apatinib and POF as first-line treatment for advanced&#xD;
      gastric cancer. Now the investigators are going to start a phase 2 trial with apatinib 500mg&#xD;
      + POF as second-line therapy to investigate the efficacy and safety in the patients with&#xD;
      advanced gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>Objective response rate</measure>
    <time_frame>From enrollment to 3 months after treatment</time_frame>
    <description>According to RECIST 1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From enrollment to progression of disease. Estimated about 12 months.</time_frame>
    <description>The length of time from enrollment until the time of progression of disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From enrollment to death of patients. Estimated about 18 months</time_frame>
    <description>The length of time from enrollment until the time of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity According to NCI CTCAE 4.03 criteria</measure>
    <time_frame>From enrollment to 3 months after treatment</time_frame>
    <description>According to NCI CTCAE 4.03 criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Apatinib plus POF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.</description>
    <arm_group_label>Apatinib plus POF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>POF</intervention_name>
    <description>The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.</description>
    <arm_group_label>Apatinib plus POF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with advanced unresectable, histologically confirmed adenocarcinoma of the&#xD;
             gastric or gastroesophageal junction.&#xD;
&#xD;
          -  Previous first-treatment with chemotherapy or radiation therapy failed. Ability to&#xD;
             take medications orally. With measurable lesions. Patients must have a performance&#xD;
             status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.&#xD;
&#xD;
          -  Without serious system dysfunction and could tolerate chemotherapy. With normal&#xD;
             marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood&#xD;
             transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of&#xD;
             ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a&#xD;
             creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min&#xD;
             (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase&#xD;
             (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.&#xD;
&#xD;
          -  Life expectancy ≥3 months. With normal electrocardiogram results and no history of&#xD;
             congestive heart failure.&#xD;
&#xD;
          -  Without bleeding and thrombosis disease. With normal coagulation function: activated&#xD;
             partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.&#xD;
&#xD;
          -  Female subjects of child-bearing potential must agree to use contraceptive measures&#xD;
             starting 1 week before the administration of the first dose of apatinib until 8 weeks&#xD;
             after discontinuing study drug. Male subjects must agree to use contraceptive measures&#xD;
             during the study and 8 weeks after last dose of study drug With written informed&#xD;
             consent signed voluntarily by patients themselves or their supervisors witted by&#xD;
             doctors.&#xD;
&#xD;
          -  With good compliance and agree to accept follow-up of disease progression and adverse&#xD;
             events.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of another neoplastic disease within the past three years,&#xD;
             excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or&#xD;
             nonmetastatic prostate cancer.&#xD;
&#xD;
          -  Patients with brain or central nervous system metastases, including leptomeningeal&#xD;
             disease.&#xD;
&#xD;
          -  Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound,&#xD;
             ulcer, or bone fracture. Significant cardiac disease as defined as: unstable angina,&#xD;
             New York Heart Association (NYHA) grade II or greater, congestive heart failure,&#xD;
             history of myocardial infarction within 6 months Evidence of bleeding diathesis or&#xD;
             coagulopathy.&#xD;
&#xD;
          -  History of a stroke or CVA within 6 months. Clinically significant peripheral vascular&#xD;
             disease. Inability to comply with study and/or follow-up procedures. Patients with any&#xD;
             other medical condition or reason, in that investigator's opinion, makes the patient&#xD;
             unstable to participate in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rongbo Lin</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongbo Lin, MD</last_name>
      <phone>86+13705919382</phone>
      <email>rongbo_lin@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rongbo Lin</name>
      <address>
        <city>Fuzhou</city>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongbo Lin</last_name>
      <phone>13705919382</phone>
      <phone_ext>13705919382</phone_ext>
      <email>rongbo_lin@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2019</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>
  </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/NCT03788174
org study id: FNF013
nct id: NCT03788174
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In previous studies,the investigators found that POF (A combination of oxaliplatin,
      fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in
      patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was
      approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced
      gastric cancer. Therefore, investigators conducted the dose escalation phase I study to
      explore the safety of combination of apatinib and POF as first-line treatment for advanced
      gastric cancer. Now the investigators are going to start a phase 2 trial with apatinib 500mg
      + POF as second-line therapy to investigate the efficacy and safety in the patients with
      advanced gastric cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: From enrollment to 3 months after treatment
description: According to RECIST 1.1
measure: Progression-free survival
time frame: From enrollment to progression of disease. Estimated about 12 months.
description: The length of time from enrollment until the time of progression of disease
measure: Overall survival
time frame: From enrollment to death of patients. Estimated about 18 months
description: The length of time from enrollment until the time of death
measure: Toxicity According to NCI CTCAE 4.03 criteria
time frame: From enrollment to 3 months after treatment
description: According to NCI CTCAE 4.03 criteria
arm group label: Apatinib plus POF
arm group type: Experimental
description: Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.
intervention type: Drug
intervention name: Apatinib
description: Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
arm group label: Apatinib plus POF
intervention type: Drug
intervention name: POF
description: The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
arm group label: Apatinib plus POF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Apatinib
sharing ipd: No