<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/NCT01669707</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingCH001</org_study_id>
    <nct_id>NCT01669707</nct_id>
  </id_info>
  <brief_title>Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)</brief_title>
  <official_title>Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chest Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Endostar pumping into vein with&#xD;
      Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly&#xD;
      in the treatment of Non-Small Cell Lung Cancer (NSCLC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endostar have anti-tumor activity by against vascular endothelial growth factor for initial&#xD;
      treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued&#xD;
      vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and&#xD;
      seeking for more effective injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 2011</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit rate (CBR)</measure>
    <time_frame>two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability</measure>
    <time_frame>two years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Endostar -Continued Pumping into+GP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endostar -injecting into +GP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endostar that is injecting into vein with Gemcitabine -Cisplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endostar -Continued Pumping into+GP</intervention_name>
    <description>Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.</description>
    <arm_group_label>Endostar -Continued Pumping into+GP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endostar -injecting into +GP</intervention_name>
    <description>Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles</description>
    <arm_group_label>Endostar -injecting into +GP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically diagnosed NSCLC;&#xD;
&#xD;
          2. primary treatment,inoperable stage IIIB/IV NSCLC;&#xD;
&#xD;
          3. Age of 18-75years; Gender Not Required;&#xD;
&#xD;
          4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:&#xD;
&#xD;
             liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function:&#xD;
             S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow&#xD;
             Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l,&#xD;
             Hb≥100 g/l;&#xD;
&#xD;
          5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;&#xD;
&#xD;
          6. The patients have explicit lung tumor lesions and the lesions were measurable;&#xD;
             (According to the standard of RECIST1.1, they should have at least one of accurately&#xD;
             measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);&#xD;
&#xD;
          7. No history of serious drug allergy;&#xD;
&#xD;
          8. Informed consent should be obtained before treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptomatic brain metastases with cognitive disorder,bone metastases with&#xD;
             complications;&#xD;
&#xD;
          2. Major organ dysfunction and Serious Heart Disease( congestive&#xD;
             heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease,&#xD;
             myocardial infarct and Resistant hypertension,);&#xD;
&#xD;
          3. Serious complications and investigator consider it is unsuited enrolling;&#xD;
&#xD;
          4. Pregnant or lactating women;&#xD;
&#xD;
          5. Allergic to research drug;&#xD;
&#xD;
          6. participating in other experimental trials and receive the treatment in four weeks;&#xD;
&#xD;
          7. The position that is for observing curative effect have a radiotherapy.&#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_contact>
    <last_name>Liyan Xu, MD</last_name>
    <email>xuliyan2009@yahoo.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Beijing Chest Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liyan Xu, MD</last_name>
      <email>xuliyan2009@yahoo.cn</email>
    </contact>
    <investigator>
      <last_name>Liyan Xu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chest Hospital</investigator_affiliation>
    <investigator_full_name>Liyan Xu</investigator_full_name>
    <investigator_title>Chief of Medical Oncology Department</investigator_title>
  </responsible_party>
  <keyword>Endostar</keyword>
  <keyword>advanced Non-small cell lung cancer</keyword>
  <keyword>Continued Pumping into vein</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Carboplatin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endostar protein</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/NCT01669707
org study id: BeijingCH001
nct id: NCT01669707
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether Endostar pumping into vein with
      Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly
      in the treatment of Non-Small Cell Lung Cancer (NSCLC).
Endostar have anti-tumor activity by against vascular endothelial growth factor for initial
      treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued
      vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and
      seeking for more effective injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival (PFS)
time frame: two years
measure: Overall survival (OS)
time frame: two years
measure: Clinical benefit rate (CBR)
time frame: two years
measure: Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability
time frame: two years
arm group label: Endostar -Continued Pumping into+GP
arm group type: Experimental
description: Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin
arm group label: Endostar -injecting into +GP
arm group type: Active Comparator
description: Endostar that is injecting into vein with Gemcitabine -Cisplatin
intervention type: Drug
intervention name: Endostar -Continued Pumping into+GP
description: Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.
arm group label: Endostar -Continued Pumping into+GP
intervention type: Drug
intervention name: Endostar -injecting into +GP
description: Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles
arm group label: Endostar -injecting into +GP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Liyan Xu, MD
email: xuliyan2009@yahoo.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chest Hospital
investigator full name: Liyan Xu
investigator title: Chief of Medical Oncology Department
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Endostar protein