<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/NCT03796364</url>
  </required_header>
  <id_info>
    <org_study_id>XQonc-008</org_study_id>
    <nct_id>NCT03796364</nct_id>
  </id_info>
  <brief_title>Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis</brief_title>
  <official_title>Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinqiao Hospital of Chongqing</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>
      To verify the efficacy and safety of endostatin in the treatment of SRILI（symptomatic&#xD;
      radiation-induced lung injury） and fibrosis. The results of this study are expected to be a&#xD;
      new clinical strategy for the treatment of radiation pneumonia and fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiotherapy is an important treatment of lung cancer, symptomatic radiation-induced lung&#xD;
      injury (SRILR) is the most common complications. In view of the important role of endostatin&#xD;
      in inhibiting angiogenesis and pro-inflammatory factors, Combined with randomized controlled&#xD;
      clinical study and small sample clinical exploration, the investigators concluded that&#xD;
      endostatin is a new clinical technique for the treatment of radiation pneumonia（RP） and&#xD;
      radiation fibrosis（RF）, which can reduce the recurrence rate of RP. In order to verify the&#xD;
      efficacy and safety of endostatin in the treatment of SRILI and fibrosis, the investigators&#xD;
      intend to use a prospective, randomized, multicenter clinical trial to classify unresectable&#xD;
      phase III-IV Non-small cell lung cancer（NSCLC） patients with SRILI above grade 2 into the&#xD;
      control group (standard SRILI treatment) and observation group (Endostar® plus standard&#xD;
      treatment) on a 1:1 randomized basis. The results of this study are expected to be a new&#xD;
      clinical strategy for the treatment of radiation pneumonia and fibrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recrudescence rate of RP（Radiation pneumonitis）</measure>
    <time_frame>at week12</time_frame>
    <description>Patients in the observation group were treated with routine radiation pneumonia and Endostar.&#xD;
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for recrudescence rate of RP at week 12. The calculation method is: number of relapse cases / total number of treatment groups × 100%; RP is classified according to CTCAE4.0, patients with grade 2 or higher are improved after treatment, and those who are assessed to be grade 2 or higher are considered recrudescence). Results are expressed as a percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>remission rate of RP</measure>
    <time_frame>at week 12</time_frame>
    <description>Patients in the observation group were treated with routine radiation pneumonia and Endostar. Results are expressed as a percentage.&#xD;
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for remission rate of RP at week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence rate of RF（Radioactive fibrosis）</measure>
    <time_frame>at week 12</time_frame>
    <description>Patients in the observation group were treated with routine radiation pneumonia and Endostar.&#xD;
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for incidence rate of RF at week 12.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Radiation Pneumonitis</condition>
  <condition>Endostatin</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard SRILI treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>observation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endostar® plus standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endostar</intervention_name>
    <description>Patients in the observation group were treated with routine radiation pneumonia and Endostar. Endostar usage: continuous intravenous pumping of Endostar(14 doses each time) over 5 days. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.</description>
    <arm_group_label>observation group</arm_group_label>
    <other_name>standard SRILI treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>standard SRILI treatment</intervention_name>
    <description>Patients in the control group were treated with current routine radiation pneumonia. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>observation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients defined as NSCLC who could not be operated on, phase III-IV;&#xD;
&#xD;
          2. EOCG PS: 0-3;&#xD;
&#xD;
          3. The clinical diagnosis is RILI, with grade 2-3;&#xD;
&#xD;
          4. No major organ dysfunction, such as heart failure and chronic obstructive pneumonia;&#xD;
&#xD;
          5. No Endostar use contraindication;&#xD;
&#xD;
          6. Volunteer to participate, good compliance, can cooperate with the test observation,&#xD;
             and sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient compliance is poor and violates the test regulations;&#xD;
&#xD;
          2. Major organ dysfunction like liver and kidney occurs, such as myocardial infarction,&#xD;
             angina pectoris, liver transaminase increased significantly;&#xD;
&#xD;
          3. Hemorrhage or thrombus occurs, anticoagulant medication is required;&#xD;
&#xD;
          4. Serious adverse drug reactions occur during treatment;&#xD;
&#xD;
          5. The patient asked to be withdrawn from the trial;&#xD;
&#xD;
          6. Other antiangiogenic drugs were used.&#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_contact>
    <last_name>Jianguo Sun, Doctor</last_name>
    <phone>8613983155736</phone>
    <email>Sunjg@aliYun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xinqiao Hospital of Chongqing</name>
      <address>
        <city>Chongqing</city>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sun Jianguo</last_name>
      <email>Sunjg@aliYun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 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>Xinqiao Hospital of Chongqing</investigator_affiliation>
    <investigator_full_name>Jianguo Sun</investigator_full_name>
    <investigator_title>Deputy director</investigator_title>
  </responsible_party>
  <keyword>endostatin</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Radiation pneumonitis</keyword>
  <keyword>Radiation fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Radiation Pneumonitis</mesh_term>
    <mesh_term>Fibrosis</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>
  <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/NCT03796364
org study id: XQonc-008
nct id: NCT03796364
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To verify the efficacy and safety of endostatin in the treatment of SRILI（symptomatic
      radiation-induced lung injury） and fibrosis. The results of this study are expected to be a
      new clinical strategy for the treatment of radiation pneumonia and fibrosis.
Radiotherapy is an important treatment of lung cancer, symptomatic radiation-induced lung
      injury (SRILR) is the most common complications. In view of the important role of endostatin
      in inhibiting angiogenesis and pro-inflammatory factors, Combined with randomized controlled
      clinical study and small sample clinical exploration, the investigators concluded that
      endostatin is a new clinical technique for the treatment of radiation pneumonia（RP） and
      radiation fibrosis（RF）, which can reduce the recurrence rate of RP. In order to verify the
      efficacy and safety of endostatin in the treatment of SRILI and fibrosis, the investigators
      intend to use a prospective, randomized, multicenter clinical trial to classify unresectable
      phase III-IV Non-small cell lung cancer（NSCLC） patients with SRILI above grade 2 into the
      control group (standard SRILI treatment) and observation group (Endostar® plus standard
      treatment) on a 1:1 randomized basis. The results of this study are expected to be a new
      clinical strategy for the treatment of radiation pneumonia and fibrosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recrudescence rate of RP（Radiation pneumonitis）
time frame: at week12
description: Patients in the observation group were treated with routine radiation pneumonia and Endostar.
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for recrudescence rate of RP at week 12. The calculation method is: number of relapse cases / total number of treatment groups × 100%; RP is classified according to CTCAE4.0, patients with grade 2 or higher are improved after treatment, and those who are assessed to be grade 2 or higher are considered recrudescence). Results are expressed as a percentage.
measure: remission rate of RP
time frame: at week 12
description: Patients in the observation group were treated with routine radiation pneumonia and Endostar. Results are expressed as a percentage.
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for remission rate of RP at week 12.
measure: incidence rate of RF（Radioactive fibrosis）
time frame: at week 12
description: Patients in the observation group were treated with routine radiation pneumonia and Endostar.
Patients in the control group were treated with current routine radiation pneumonia. Chest CT were assessed for incidence rate of RF at week 12.
arm group label: control group
arm group type: Active Comparator
description: standard SRILI treatment
arm group label: observation group
arm group type: Experimental
description: Endostar® plus standard treatment
intervention type: Drug
intervention name: Endostar
description: Patients in the observation group were treated with routine radiation pneumonia and Endostar. Endostar usage: continuous intravenous pumping of Endostar(14 doses each time) over 5 days. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.
arm group label: observation group
other name: standard SRILI treatment
intervention type: Drug
intervention name: standard SRILI treatment
description: Patients in the control group were treated with current routine radiation pneumonia. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.
arm group label: control group
arm group label: observation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jianguo Sun, Doctor
phone: 8613983155736
email: Sunjg@aliYun.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinqiao Hospital of Chongqing
investigator full name: Jianguo Sun
investigator title: Deputy director
mesh term: Pneumonia
mesh term: Radiation Pneumonitis
mesh term: Fibrosis
mesh term: Endostar protein
sharing ipd: No