<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/NCT01679327</url>
  </required_header>
  <id_info>
    <org_study_id>WY0524</org_study_id>
    <nct_id>NCT01679327</nct_id>
  </id_info>
  <brief_title>Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer</brief_title>
  <official_title>Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the relationship of biomarker expression and efficacy of bevacizumab&#xD;
      plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the&#xD;
      treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3&#xD;
      expression in tumor tissue by IHC and detect those protein expression level in plasma by&#xD;
      ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D&#xD;
      expression level in plasma by ELISA. The aim of the study is to identify whether those&#xD;
      biomarkers could predict Bevacizumab efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</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>Overall response rate</measure>
    <time_frame>36 months</time_frame>
    <description>During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>36 months</time_frame>
    <description>The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>36 months</time_frame>
    <description>From the time patients receive the first cycle chemotherapy to the time they die for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>36 months</time_frame>
    <description>Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Bevacizumab plus chemotherapy（XELOX or FOLFOX）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <arm_group_label>Bevacizumab plus chemotherapy（XELOX or FOLFOX）</arm_group_label>
    <other_name>Eloxatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xeloda</intervention_name>
    <arm_group_label>Bevacizumab plus chemotherapy（XELOX or FOLFOX）</arm_group_label>
    <other_name>Capetabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium folinate (CF)</intervention_name>
    <arm_group_label>Bevacizumab plus chemotherapy（XELOX or FOLFOX）</arm_group_label>
    <other_name>Calcium folinate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-FU</intervention_name>
    <arm_group_label>Bevacizumab plus chemotherapy（XELOX or FOLFOX）</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <arm_group_label>Bevacizumab plus chemotherapy（XELOX or FOLFOX）</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  More than 18-years old,male or female&#xD;
&#xD;
          -  Pathologically approved as unresectable/metastatic colorectal cancer&#xD;
&#xD;
          -  KPS &gt; 70% or ECOG 0-2&#xD;
&#xD;
          -  HGB &gt; 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR &lt; 1.5 x Upper normality，&#xD;
&#xD;
          -  TB &lt; 1.5 X Upper normality，AST or ALT &lt; 2.5 x Upper normality.&#xD;
&#xD;
          -  Signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer&#xD;
&#xD;
          -  Pregnancy or in lactation&#xD;
&#xD;
          -  HGB &lt; 80 g/L, NEUT &lt; 1.5x109 /L, PLT &lt; 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥ 2.5&#xD;
             X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality&#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>Yihebali Chi, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jinwan WANG</last_name>
    <role>Study Director</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Institute&amp;Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yihebali Chi, MD</last_name>
      <phone>8610-87788145</phone>
      <email>Yihebalichi@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>September 5, 2012</last_update_submitted>
  <last_update_submitted_qc>September 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>yihebali chi</investigator_full_name>
    <investigator_title>associated professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Calcium</mesh_term>
    <mesh_term>Levoleucovorin</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/NCT01679327
org study id: WY0524
nct id: NCT01679327
lead sponsor: 
has dmc: No
This study evaluates the relationship of biomarker expression and efficacy of bevacizumab
      plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the
      treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3
      expression in tumor tissue by IHC and detect those protein expression level in plasma by
      ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D
      expression level in plasma by ELISA. The aim of the study is to identify whether those
      biomarkers could predict Bevacizumab efficacy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate
time frame: 36 months
description: During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.
measure: progression free survival
time frame: 36 months
description: The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason.
measure: overall survival
time frame: 36 months
description: From the time patients receive the first cycle chemotherapy to the time they die for any reason.
measure: Number of Participants with Adverse Events
time frame: 36 months
description: Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0
arm group label: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
arm group type: Experimental
description: Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)
intervention type: Drug
intervention name: Oxaliplatin
arm group label: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
other name: Eloxatin
intervention type: Drug
intervention name: Xeloda
arm group label: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
other name: Capetabine
intervention type: Drug
intervention name: Calcium folinate (CF)
arm group label: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
other name: Calcium folinate
intervention type: Drug
intervention name: 5-FU
arm group label: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
intervention type: Drug
intervention name: Bevacizumab
arm group label: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
other name: Avastin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yihebali Chi, Doctor
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Jinwan WANG
role: Study Director
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: yihebali chi
investigator title: associated professor
mesh term: Colorectal Neoplasms
mesh term: Calcium, Dietary
mesh term: Leucovorin
mesh term: Bevacizumab
mesh term: Oxaliplatin
mesh term: Calcium
mesh term: Levoleucovorin