<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/NCT04473703</url>
  </required_header>
  <id_info>
    <org_study_id>SHXKYY202005</org_study_id>
    <nct_id>NCT04473703</nct_id>
  </id_info>
  <brief_title>Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients</brief_title>
  <official_title>A Prospective Study of Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in Non-Small Cell Lung Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Chest Hospital</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>
      This is a prospective, open label, single arm study. A total of 300 patients with primary&#xD;
      non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are&#xD;
      expected to included . All patients will follow up for at least 1 year. Patients with cardiac&#xD;
      adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or&#xD;
      during the subsequently follow-up period will randomly assigned a random number to each&#xD;
      patient by computer random sequence. Patients with odd random number will treat with&#xD;
      RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with&#xD;
      ARNI（angiotensin-receptor-neprilysin inhibitor）.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>1 year</time_frame>
    <description>a) Primary Outcome is Major Adverse Cardiovascular Events（MACE）related to ICIs，includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Common Terminology Criteria for Adverse Events (CTCAE)</measure>
    <time_frame>1 year</time_frame>
    <description>Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause of death</measure>
    <time_frame>1 year</time_frame>
    <description>every reason that cause patient's death after ICIs treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>examination indexes</measure>
    <time_frame>1 year</time_frame>
    <description>The examination indexes that related to myocardial damage</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Adverse Reactions</condition>
  <condition>Immune Checkpoint Inhibitor</condition>
  <condition>Non-Small Cell Lung Cancer Patients</condition>
  <condition>Cardiac Event</condition>
  <arm_group>
    <arm_group_label>observation group</arm_group_label>
    <description>A total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor</intervention_name>
    <description>Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）</description>
    <arm_group_label>observation group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1&#xD;
        immune checkpoint inhibitors(ICIs) are expected to included. And then the basic information&#xD;
        and the examination results will be collected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be willing and able to provide written informed consent/assent for the trial;&#xD;
&#xD;
          2. Lung cancer patients whose pathological results confirmed is primary non-small cell&#xD;
             lung cancer, stage III~IV;&#xD;
&#xD;
          3. Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least&#xD;
             two courses;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who do not have pathological diagnosis;&#xD;
&#xD;
          2. Patients who can't finish the follow-up;&#xD;
&#xD;
          3. The anti-PD-1, anti-PD-L1 therapy was less than two courses;&#xD;
&#xD;
          4. Patients whose cancer diagnosed with small cell lung cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yunhua Xu</last_name>
    <phone>86-021-22200000</phone>
    <email>yhxu@shchest.org</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Xumin Hou</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04473703
org study id: SHXKYY202005
nct id: NCT04473703
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, open label, single arm study. A total of 300 patients with primary
      non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are
      expected to included . All patients will follow up for at least 1 year. Patients with cardiac
      adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or
      during the subsequently follow-up period will randomly assigned a random number to each
      patient by computer random sequence. Patients with odd random number will treat with
      RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with
      ARNI（angiotensin-receptor-neprilysin inhibitor）.
observational model: Cohort
time perspective: Prospective
measure: Major Adverse Cardiovascular Events
time frame: 1 year
description: a) Primary Outcome is Major Adverse Cardiovascular Events（MACE）related to ICIs，includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission
measure: Common Terminology Criteria for Adverse Events (CTCAE)
time frame: 1 year
description: Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease
measure: All cause of death
time frame: 1 year
description: every reason that cause patient's death after ICIs treatment
measure: examination indexes
time frame: 1 year
description: The examination indexes that related to myocardial damage
arm group label: observation group
description: A total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed.
intervention type: Drug
intervention name: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor
description: Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）
arm group label: observation group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yunhua Xu
phone: 86-021-22200000
email: yhxu@shchest.org
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Xumin Hou
investigator title: Chief physician
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Cardiovascular Diseases
sharing ipd: Undecided