<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/NCT03787953</url>
  </required_header>
  <id_info>
    <org_study_id>PDL1-2018-301BJ</org_study_id>
    <nct_id>NCT03787953</nct_id>
  </id_info>
  <brief_title>A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors</brief_title>
  <official_title>A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LinkDoc Technology (Beijing) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese PLA General Hospital</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 study was designed to analyze the efficacy and safety of anti-PD-1/PD-L1 antibodies for&#xD;
      the treatment of advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a real-world study and the case records of patients with advanced solid tumors&#xD;
      who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019&#xD;
      and received anti-PD-1/PD-L1 antibody therapy will be collected in this study. The medical&#xD;
      data including patient demographic, tumor characteristics, laboratory examination, history of&#xD;
      treatments, adverse reactions, and so on will be extracted to analyze the effectivity and&#xD;
      safety of anti-PD-1/PD-L1 antibodies and explore the prognosis-relevant factors of advanced&#xD;
      solid tumors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 30, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>6 months</time_frame>
    <description>PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy.</measure>
    <time_frame>up to 4 weeks after the last dose</time_frame>
    <description>AEs/SAEs were evaluated using NCI-CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>6 months</time_frame>
    <description>ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>6 months</time_frame>
    <description>DCR was defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>up to 12 months</time_frame>
    <description>OS was defined as the length of time from the administration of the first-dose until death from any cause.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarkers</measure>
    <time_frame>before the first dose</time_frame>
    <description>Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Anti-PD-1/PD-L1 antibodies</arm_group_label>
    <description>Patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-PD-1/PD-L1 antibodies</intervention_name>
    <description>The study is a real-world study. According to the actual medical history of patients, the usage of anti-PD-1/PD-L1 antibodies was collected.</description>
    <arm_group_label>Anti-PD-1/PD-L1 antibodies</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsy specimen or blood specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA&#xD;
        General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically or cytologically confirmed advanced solid tumors;&#xD;
&#xD;
          -  Received anti-PD-1/PD-L1 antibody therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No specific exclusion criteria in this real world study.&#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>Shunchang Jiao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiao Zhao, PhD</last_name>
    <phone>+86-15210417668</phone>
    <email>rws2018@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao Zhao, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Shunchang Jiao, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiao Zhao, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Xiao Zhao</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>anti-PD-1/PD-L1 antibodies</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Safety</keyword>
  <keyword>Real world study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</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/NCT03787953
org study id: PDL1-2018-301BJ
nct id: NCT03787953
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study was designed to analyze the efficacy and safety of anti-PD-1/PD-L1 antibodies for
      the treatment of advanced solid tumors.
The study is a real-world study and the case records of patients with advanced solid tumors
      who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019
      and received anti-PD-1/PD-L1 antibody therapy will be collected in this study. The medical
      data including patient demographic, tumor characteristics, laboratory examination, history of
      treatments, adverse reactions, and so on will be extracted to analyze the effectivity and
      safety of anti-PD-1/PD-L1 antibodies and explore the prognosis-relevant factors of advanced
      solid tumors.
observational model: Cohort
time perspective: Cross-Sectional
measure: Progression-free survival (PFS)
time frame: 6 months
description: PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.
measure: Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy.
time frame: up to 4 weeks after the last dose
description: AEs/SAEs were evaluated using NCI-CTCAE v5.0
measure: Objective Response Rate (ORR)
time frame: 6 months
description: ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST).
measure: Disease Control Rate (DCR)
time frame: 6 months
description: DCR was defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST).
measure: Overall survival (OS)
time frame: up to 12 months
description: OS was defined as the length of time from the administration of the first-dose until death from any cause.
measure: Biomarkers
time frame: before the first dose
description: Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI
arm group label: Anti-PD-1/PD-L1 antibodies
description: Patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy
intervention type: Drug
intervention name: Anti-PD-1/PD-L1 antibodies
description: The study is a real-world study. According to the actual medical history of patients, the usage of anti-PD-1/PD-L1 antibodies was collected.
arm group label: Anti-PD-1/PD-L1 antibodies
Biopsy specimen or blood specimen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shunchang Jiao, PhD
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Xiao Zhao, PhD
phone: +86-15210417668
email: rws2018@aliyun.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Xiao Zhao
investigator title: Principal Investigator
mesh term: Neoplasms
mesh term: Antibodies
sharing ipd: No