<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/NCT02995187</url>
  </required_header>
  <id_info>
    <org_study_id>CH-L-061</org_study_id>
    <nct_id>NCT02995187</nct_id>
  </id_info>
  <brief_title>Study of Apatinib as Third-line and Later Therapy in Patients With Small Cell Lung Cancer (SCLC)</brief_title>
  <official_title>A Non-randomized, Open-label, Prospective, Single-center Study of Apatinib Mesylate Tablet as Third-line and Later Therapy in Patients With Small Cell Cancer（SCLC）</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial&#xD;
      evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients&#xD;
      with small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and&#xD;
      etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive&#xD;
      small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is&#xD;
      no standard treatment recommendation for this group of patients who failed to second-line&#xD;
      therapy and had good performance status. Apatinib has been approved as a second-line&#xD;
      treatment for advanced gastric cancer. Several phase III clinical studies of non small cell&#xD;
      lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less&#xD;
      toxic side effects and better patient tolerance. However, the clinical application of&#xD;
      apatinib in small cell lung cancer is still lack of evidence-based medicine. And this&#xD;
      clinical trial is designed to prospectively investigate the efficacy and safety of apatinib&#xD;
      in recurrent SCLC patients in our center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">May 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</measure>
    <time_frame>up to 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>up to 3 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>tumor phosphorylated VEGFR2 (p-VEGFR2) expressions</measure>
    <time_frame>baseline</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib Mesylate tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received oral apatinib 500 mg in tablet once daily, a treatment cycle was defined as 28 days (4 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib Mesylate tablet</intervention_name>
    <description>Apatinib 500 mg in tablet once daily</description>
    <arm_group_label>Apatinib Mesylate tablet</arm_group_label>
    <other_name>Apatinib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years to 75 years;&#xD;
&#xD;
          2. Had a histologically or cytologically confirmed diagnosis of SCLC;&#xD;
&#xD;
          3. Had received at least 2 lines chemotherapy regimen and must include basis of the&#xD;
             platinum regimen after which disease diagnosed;&#xD;
&#xD;
          4. Have not received VEGFR-TKI;&#xD;
&#xD;
          5. Had a life expectancy of at least 3 months;&#xD;
&#xD;
          6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or&#xD;
             2;&#xD;
&#xD;
          7. Had a disease status that was measurable or evaluable as defined by Response&#xD;
             Evaluation Criteria in Solid Tumors (RECIST, version1.1), larger than 10 mm in&#xD;
             diameter by spiral CT scan;&#xD;
&#xD;
          8. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L,&#xD;
             platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper&#xD;
             limit of normal(ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum&#xD;
             transaminase≤5×the ULN), serum creatine ≤ 1.25 x ULN, creatinine clearance rate &gt;&#xD;
             45ml/min;&#xD;
&#xD;
          9. For women of child-bearing age, the pregnancy test results (serum or urine) within 7&#xD;
             days before enrolment must be negative. They will take appropriate methods for&#xD;
             contraception during the study until the 8th week post the last administration of&#xD;
             study drug. For men (previous surgical sterilization accepted), will take appropriate&#xD;
             methods for contraception during the study until the 8th week post the last&#xD;
             administration of study drug;&#xD;
&#xD;
         10. Signed and dated informed consent.Willingness and ability to comply with scheduled&#xD;
             visits, treatment plans, laboratory tests, and other study procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with non-small cell lung cancer;&#xD;
&#xD;
          2. Imaging (CT or MRI) results indicate that the existence of central tumors locally&#xD;
             invading the large vessel could be detected, or apparent pulmonary cavity or&#xD;
             necrotizing tumors;&#xD;
&#xD;
          3. Patients with clinical symptoms of brain metastases or meningeal metastasis;&#xD;
&#xD;
          4. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg&#xD;
             and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;&#xD;
&#xD;
          5. Suffered from grade II or above myocardial ischemia or myocardial infarction,&#xD;
             uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade&#xD;
             III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria&#xD;
             or echocardiography check: left ventricular ejection fraction (LVEF)&lt;50%;&#xD;
&#xD;
          6. Coagulant function abnormality (INR &gt; 1.5 or prothrombin time (PT) &gt; ULN + 4 seconds&#xD;
             or APTT ULN &gt; 1.5), with bleeding tendency or is treated with thrombolysis and&#xD;
             anticoagulation;&#xD;
&#xD;
          7. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that&#xD;
             the 24-h urine protein quantitation ≥ 1.0 g;&#xD;
&#xD;
          8. Patients who received major surgical operations or experienced severe traumatic&#xD;
             injuries, bone fracture, or ulcers within 4 weeks before screening;&#xD;
&#xD;
          9. Patients who had obvious hemoptysis within 2 months before screening, or experienced&#xD;
             daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; Patients&#xD;
             who experienced bleeding symptoms of clinical significance , or with confirmed&#xD;
             bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer,&#xD;
             baseline occult blood in stool ++ and above, or vasculitis, etc;&#xD;
&#xD;
         10. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident&#xD;
             (including transient ischemic attack), deep venous thrombosis and pulmonary embolism,&#xD;
             etc., within 12 months before screening;&#xD;
&#xD;
         11. Allergic to any ingredients of Apatinib;&#xD;
&#xD;
         12. Evidence of significant medical illness that in the investigator's judgment will&#xD;
             substantially increase the risk associated with the subject's participation in and&#xD;
             completion of 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>Yutao Liu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yutao Liu, M.D.</last_name>
    <phone>+8613911901165</phone>
    <email>13911901165@139.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yutao Liu, MD</last_name>
      <email>13911901165@139.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</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>Yutao Liu</investigator_full_name>
    <investigator_title>Associate Chief Physician</investigator_title>
  </responsible_party>
  <keyword>Apatinib</keyword>
  <keyword>Third-line and Later Therapy</keyword>
  <keyword>Small Cell Lung Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</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/NCT02995187
org study id: CH-L-061
nct id: NCT02995187
lead sponsor: 
has dmc: Yes
This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial
      evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients
      with small cell lung cancer.
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and
      etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive
      small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is
      no standard treatment recommendation for this group of patients who failed to second-line
      therapy and had good performance status. Apatinib has been approved as a second-line
      treatment for advanced gastric cancer. Several phase III clinical studies of non small cell
      lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less
      toxic side effects and better patient tolerance. However, the clinical application of
      apatinib in small cell lung cancer is still lack of evidence-based medicine. And this
      clinical trial is designed to prospectively investigate the efficacy and safety of apatinib
      in recurrent SCLC patients in our center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: up to 3 years
measure: Overall survival
time frame: up to 3 years
measure: Disease Control Rate
time frame: up to 3 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: up to 3 years
measure: tumor phosphorylated VEGFR2 (p-VEGFR2) expressions
time frame: baseline
arm group label: Apatinib Mesylate tablet
arm group type: Experimental
description: Patients received oral apatinib 500 mg in tablet once daily, a treatment cycle was defined as 28 days (4 weeks).
intervention type: Drug
intervention name: Apatinib Mesylate tablet
description: Apatinib 500 mg in tablet once daily
arm group label: Apatinib Mesylate tablet
other name: Apatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yutao Liu, M.D.
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Yutao Liu, M.D.
phone: +8613911901165
email: 13911901165@139.com
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: Yutao Liu
investigator title: Associate Chief Physician
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Apatinib
sharing ipd: No