<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/NCT03797625</url>
  </required_header>
  <id_info>
    <org_study_id>ENDO-SH-002</org_study_id>
    <nct_id>NCT03797625</nct_id>
  </id_info>
  <brief_title>Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas</brief_title>
  <official_title>Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this study is to explore whether endostar combined with IP as treatment could&#xD;
      improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy&#xD;
      regimens&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to explore whether endostar combined with IP as treatment could improve&#xD;
      progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens&#xD;
      used as second-line treatment of advanced esophageal squamous cell carcinomas&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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>from the first cycle of treatment (day one) to two month after the last cycle</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Endostar Combined With IP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endostar15mg/m2 Irinotecan 60mg/m2，D1，8 DDP 60mg/m2，D1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>60mg/m2，D1，8</description>
    <arm_group_label>Endostar Combined With IP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DDP</intervention_name>
    <description>60mg/m2，D1</description>
    <arm_group_label>Endostar Combined With IP</arm_group_label>
    <other_name>Cisplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endostar</intervention_name>
    <description>15mg/d，d1-d7 civ</description>
    <arm_group_label>Endostar Combined With IP</arm_group_label>
    <other_name>ENDO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Histologically proven primary thoracic esophageal squamous cell carcinoma According to the&#xD;
        esophageal AJCC2009 7th to determine new stage IV esophageal cancer The subject has PD&#xD;
        after first-line chemotherapy or radiation within a year Presence of at least one index&#xD;
        lesion measurable by CT scan or MRI according to RECIST 1.1 Can eat more than liquid diet;&#xD;
        No signs before esophageal perforation 18~75 years PS:0-1 Life expectancy of ≥ 3 months ANC&#xD;
        ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL Ccr≤&#xD;
        UNL,Scr≥60 mL/min Normal electrocardiogram (ecg), the body had no unheal wounds&#xD;
        Radiotherapy before within the scope of the normal dose and not affect subsequent treatment&#xD;
        Prior to biological agents, especially e. coli genetically engineered products without&#xD;
        severe allergic reactions Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Breast-feeding or pregnant women, no effective contraception if risk of conception exists&#xD;
        Chronic diarrhea, enteritis, intestine obstruction which are not under control Esophageal&#xD;
        obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or&#xD;
        hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious&#xD;
        lung complications, etc.&#xD;
&#xD;
        A second primary tumor (except skin basal cell carcinoma) The original serious heart&#xD;
        disease, including: higher risk of congestive heart failure, unable to control arrhythmia,&#xD;
        unstable angina, myocardial infarction, severe valvular heart disease, and resistant&#xD;
        hypertension With uncontrol nerve, mental illness or mental disorders, compliance is poor,&#xD;
        can't cooperate with accounts and response to treatment; Primary brain tumors or CNS&#xD;
        metastases illness did not get a control, has obvious cranial hypertension or nerve mental&#xD;
        symptoms With bleeding tendency Has inherited bleeding evidence of physical or blood&#xD;
        coagulation disorder With clear chemotherapy drug allergy Other researchers believe that&#xD;
        patients should not participate in this testing&#xD;
&#xD;
        -&#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>chang jian hua, PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PI</affiliation>
  </overall_official>
  <overall_official>
    <last_name>wang hui jie, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>SUBI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>chang jian hua, PD</last_name>
    <phone>18017312689</phone>
    <email>changjianhua@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chang jian hua, PD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Chang Jian Hua</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
    <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/NCT03797625
org study id: ENDO-SH-002
nct id: NCT03797625
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to explore whether endostar combined with IP as treatment could
      improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy
      regimens
This study is to explore whether endostar combined with IP as treatment could improve
      progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens
      used as second-line treatment of advanced esophageal squamous cell carcinomas
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: from the first cycle of treatment (day one) to two month after the last cycle
arm group label: Endostar Combined With IP
arm group type: Experimental
description: Endostar15mg/m2 Irinotecan 60mg/m2，D1，8 DDP 60mg/m2，D1
intervention type: Drug
intervention name: Irinotecan
description: 60mg/m2，D1，8
arm group label: Endostar Combined With IP
intervention type: Drug
intervention name: DDP
description: 60mg/m2，D1
arm group label: Endostar Combined With IP
other name: Cisplatin
intervention type: Drug
intervention name: Endostar
description: 15mg/d，d1-d7 civ
arm group label: Endostar Combined With IP
other name: ENDO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: chang jian hua, PD
role: Principal Investigator
affiliation: PI
last name: wang hui jie, doctor
role: Principal Investigator
affiliation: SUBI
last name: chang jian hua, PD
phone: 18017312689
email: changjianhua@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Chang Jian Hua
investigator title: Chief Physician
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Cisplatin
mesh term: Irinotecan
mesh term: Endostar protein