<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/NCT03274011</url>
  </required_header>
  <id_info>
    <org_study_id>ESO-Shanghai11</org_study_id>
    <nct_id>NCT03274011</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma</brief_title>
  <official_title>Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma: A Phase II, Prospective, Single-arm, Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is no standard treatment strategy for recurrent or metastatic esophageal squamous cell&#xD;
      carcinoma patients now, especially after the second-line treatment. Most of the patients have&#xD;
      the bad ECOG (Eastern Cooperative Oncology Group) score and prognosis. Chemotherapy,&#xD;
      radiotherapy, surgery are usually unacceptable for them. Previous data showed that apatinib&#xD;
      treatment significantly improved OS(overall survival) and PFS(progression-free survival) with&#xD;
      an acceptable safety profile in patients with advanced gastric cancer refractory to two or&#xD;
      more lines of prior chemotherapy. The study will observe the efficacy and safety of Apatinib&#xD;
      for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective,&#xD;
      single-arm, multicenter trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">June 26, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 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>Progression Free Survival</measure>
    <time_frame>12 weeks</time_frame>
    <description>the time with no progression from the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>24 weeks</time_frame>
    <description>the time from the treatment to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>partial response and complete response</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Esophageal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Apatinib Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular en-dothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. Previous data showed that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.</description>
    <arm_group_label>Apatinib Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient age: ≥18 years old&#xD;
&#xD;
          2. An ECOG score of 0-2&#xD;
&#xD;
          3. Pathologically diagnosed with Esophageal Squamous Cell Carcinoma.&#xD;
&#xD;
          4. At least second-line treatment failure regimens without targeted therapy.&#xD;
&#xD;
          5. Measurable lesion.&#xD;
&#xD;
          6. An expected survival of ≥ 3 months.&#xD;
&#xD;
          7. Major organ function had to meet the following criteria:&#xD;
&#xD;
        1)For regular test results: HB(hemoglobin) ≥ 90g / L (14 days without blood transfusion);&#xD;
        ANC(absolute neutrophil count) ≥ 1.5 × 109 / L; PLT(platelet) ≥ 80 × 109 / L 2)Biochemical&#xD;
        tests results: Bilirubin &lt;1.5 times the upper limit of normal (ULN) ALT(Alanine&#xD;
        aminotransferase) and AST≤2.5 × ULN; liver metastases, if any, the ALT and AST≤5 × ULN;&#xD;
        Endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula) 8. Informing consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previously or presently suffering from other malignancies, except for the cured and&#xD;
             stable carcinoma;&#xD;
&#xD;
          2. Pregnant or lactating women;&#xD;
&#xD;
          3. Participation in clinical trials with other drugs in the preceding four weeks.&#xD;
&#xD;
          4. Factors that could have an effect on oral medication (such as inability to swallow,&#xD;
             chronic diarrhea and intestinal obstruction).&#xD;
&#xD;
          5. Serious bleeding events within 4weeks (≥3 degree)-CTCAE(Common Terminology Criteria&#xD;
             for Adverse Events) 4.0&#xD;
&#xD;
          6. Central nervous system metastasis or a history of central nervous system metastasis.&#xD;
&#xD;
          7. Hypertension and antihypertensive drug treatment that does not normalize blood&#xD;
             pressures (systolic blood pressure&gt; 140 mmHg and diastolic blood pressure &gt; 90 mm Hg);&#xD;
             With unstable angina pectoris; Arrhythmia; Coronary heart disease greater than Class&#xD;
             II; Angina pectoris diagnosed with 3 months or myocardial infarction event occurs&#xD;
             within 6 months before recruiting.&#xD;
&#xD;
          8. With the open wounds or fractura.&#xD;
&#xD;
          9. A history of organ transplant.&#xD;
&#xD;
         10. Coagulation dysfunction (PT(prothrombin time)&gt;16 s, APTT(activated partial&#xD;
             thromboplastin time)&gt;43 s, TT(thrombin time)&gt;21 s, Fbg(Fibrinogen)&lt;2g/L), a tendency&#xD;
             to bleed or receiving thrombolytic or anticoagulant therapy.&#xD;
&#xD;
         11. A history of abuse of psychotropic drugs or mental disorders.&#xD;
&#xD;
         12. Central nervous system disorders.&#xD;
&#xD;
         13. A history of immunodeficiency.&#xD;
&#xD;
         14. Arterial/venous thrombosis events within 12 months before recruiting.&#xD;
&#xD;
         15. Use of CFDA(China Food and Drug Administration) approved anti-gastric modern&#xD;
             traditional Chinese medicine preparations and immunomodulatory agents.&#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>kuaile zhao, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Yangpu District East Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 24, 2021</last_update_submitted>
  <last_update_submitted_qc>January 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Kuai Le Zhao, MD</investigator_full_name>
    <investigator_title>Chief of Chest Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</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>Apatinib</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/NCT03274011
org study id: ESO-Shanghai11
nct id: NCT03274011
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
There is no standard treatment strategy for recurrent or metastatic esophageal squamous cell
      carcinoma patients now, especially after the second-line treatment. Most of the patients have
      the bad ECOG (Eastern Cooperative Oncology Group) score and prognosis. Chemotherapy,
      radiotherapy, surgery are usually unacceptable for them. Previous data showed that apatinib
      treatment significantly improved OS(overall survival) and PFS(progression-free survival) with
      an acceptable safety profile in patients with advanced gastric cancer refractory to two or
      more lines of prior chemotherapy. The study will observe the efficacy and safety of Apatinib
      for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective,
      single-arm, multicenter trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 12 weeks
description: the time with no progression from the treatment
measure: Overall Survival
time frame: 24 weeks
description: the time from the treatment to death
measure: Overall Response Rate
time frame: 4 weeks
description: partial response and complete response
arm group label: Apatinib Treatment
arm group type: Experimental
description: Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
intervention type: Drug
intervention name: Apatinib
description: Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular en-dothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. Previous data showed that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.
arm group label: Apatinib Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: kuaile zhao, doctor
role: Principal Investigator
affiliation: Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China.
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Kuai Le Zhao, MD
investigator title: Chief of Chest Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Esophageal Neoplasms
mesh term: Apatinib