<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/NCT04500990</url>
  </required_header>
  <id_info>
    <org_study_id>MRI immunotherapy</org_study_id>
    <nct_id>NCT04500990</nct_id>
  </id_info>
  <brief_title>MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study</brief_title>
  <official_title>Magnetic Resonance Imaging (MRI) Diffusion-weighted Imaging (Dwi) None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking 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>
      This is a prospective two cohorts observational study aimed to investigate the predicting&#xD;
      value of MRI none-Gaussian model in digestive malignancies patients who received single agent&#xD;
      PD-1/PD-L1 inhibitor or combined immunotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>Objective Response Rate</measure>
    <time_frame>from enrollment of the first subject until the database cut-off approximately 12 months later.</time_frame>
    <description>The rate of patients reached complete response or partial response.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress free survival</measure>
    <time_frame>from enrollment of the first subject until the database cut-off approximately 12 months later.</time_frame>
    <description>the time from enrollment to disease progression or death or loss of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>from enrollment of the first subject until the database cut-off approximately 12 months later.</time_frame>
    <description>the time from enrollment to death or loss of follow-up.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Immunotherapy</condition>
  <condition>Digestive System Neoplasm</condition>
  <arm_group>
    <arm_group_label>Single agent PD-1/PD-L1 inhibitor</arm_group_label>
    <description>Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined immunotherapy</arm_group_label>
    <description>Patients will receive combined immunotherapy in a predefined group. PD-1/PD-L1 inhibitor will be combined with target therapy, such as lenvatinib, enrotinib, herceptin et al.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>MRI test</intervention_name>
    <description>Patients will receive diagnostic MRI test on d0.</description>
    <arm_group_label>Combined immunotherapy</arm_group_label>
    <arm_group_label>Single agent PD-1/PD-L1 inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>MRI test</intervention_name>
    <description>Patients will receive diagnostic MRI test on d8±1.</description>
    <arm_group_label>Combined immunotherapy</arm_group_label>
    <arm_group_label>Single agent PD-1/PD-L1 inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>MRI test</intervention_name>
    <description>Patients will receive diagnostic MRI test on d30±2.</description>
    <arm_group_label>Combined immunotherapy</arm_group_label>
    <arm_group_label>Single agent PD-1/PD-L1 inhibitor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receive treatment in Beijing Cancer Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years, ECOG 0-1, expected survival ≥3 months;&#xD;
&#xD;
          -  pathologically confirmed digestive system adenocarcinoma, including but not restricted&#xD;
             to gastric adenocarcinoma, colorectal cancer, pancreatic adenocarcinoma et al;&#xD;
&#xD;
          -  pathologically confirmed PD-L1 expression, or MMR-deficient (dMMR)/microsatellite&#xD;
             instability (MSI-H) or high tumor mutation burden (TMB-H) or other indication for&#xD;
             immunotherapy;&#xD;
&#xD;
          -  at least one target lesion, if there is no target lesion the thickness of cavity&#xD;
             viscera lesion should exceed 1cm;&#xD;
&#xD;
          -  patients will receive single agent PD-1/PD-L1 inhibitor, or combined immunotherapy&#xD;
             such as: lenvatinib, enrotinib or herceptin;&#xD;
&#xD;
          -  screening laboratory values must meet the following criteria: hemoglobin ≥ 9.0 g/dL;&#xD;
             neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 2.0 x&#xD;
             upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase&#xD;
             (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine&#xD;
             ≤1.5 x ULN, and serum creatinine rate &gt;50μmol/L; activated partial thromboplastin time&#xD;
             (APTT)、international normalized ratio (INR), prothrombin lime (PT)≤1.5×ULN;&#xD;
&#xD;
          -  echocardiography: left ventricular ejection fraction≥50%&#xD;
&#xD;
          -  volunteer participate, signed written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  claustrophobia or other contraindication for MRI testing;&#xD;
&#xD;
          -  received prior anti-PD-1/PD-L1 or other immune checkpoint inhibitors;&#xD;
&#xD;
          -  combined immunotherapy contains chemotherapy agent;&#xD;
&#xD;
          -  contain other histology component except adenocarcinoma；&#xD;
&#xD;
          -  hypersensitivity after other monoclonal antibody infusion；&#xD;
&#xD;
          -  coexist other malignancy in last five years;&#xD;
&#xD;
          -  active autoimmune disease, or who received systemic treatment with corticosteroids (&gt;&#xD;
             10 mg daily prednisone equivalent) or other immunosuppressive medications within 2&#xD;
             weeks of first dose;&#xD;
&#xD;
          -  Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well&#xD;
             controlled, and need locally treatment or repeated drainage;&#xD;
&#xD;
          -  obvious bleeding tendency or had CTCAE≥3 grade；&#xD;
&#xD;
          -  subjects are eligible with clinically controlled and stable neurologic function ≥ 4&#xD;
             weeks, which is no evidence of CNS disease progression; subjects with spinal cord&#xD;
             compression and cancerous meningitis are not eligible；&#xD;
&#xD;
          -  vaccination within 28 days of the first administration of trial treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Lin Shen, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lin Shen, professor</last_name>
    <phone>86-10-88196561</phone>
    <email>linshenpku@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lin Shen, MD PhD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shen Lin, Professor</last_name>
      <phone>010-88196561</phone>
      <email>Linshenpku@163.com</email>
    </contact>
    <investigator>
      <last_name>Shen Lin, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Shen Lin</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>DWI</keyword>
  <keyword>Digestive system malignancies</keyword>
  <keyword>Early response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
  </condition_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/NCT04500990
org study id: MRI immunotherapy
nct id: NCT04500990
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective two cohorts observational study aimed to investigate the predicting
      value of MRI none-Gaussian model in digestive malignancies patients who received single agent
      PD-1/PD-L1 inhibitor or combined immunotherapy.
observational model: Cohort
time perspective: Prospective
measure: Objective Response Rate
time frame: from enrollment of the first subject until the database cut-off approximately 12 months later.
description: The rate of patients reached complete response or partial response.
measure: Progress free survival
time frame: from enrollment of the first subject until the database cut-off approximately 12 months later.
description: the time from enrollment to disease progression or death or loss of follow-up.
measure: Overall survival
time frame: from enrollment of the first subject until the database cut-off approximately 12 months later.
description: the time from enrollment to death or loss of follow-up.
arm group label: Single agent PD-1/PD-L1 inhibitor
description: Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group.
arm group label: Combined immunotherapy
description: Patients will receive combined immunotherapy in a predefined group. PD-1/PD-L1 inhibitor will be combined with target therapy, such as lenvatinib, enrotinib, herceptin et al.
intervention type: Radiation
intervention name: MRI test
description: Patients will receive diagnostic MRI test on d0.
arm group label: Combined immunotherapy
arm group label: Single agent PD-1/PD-L1 inhibitor
intervention type: Radiation
intervention name: MRI test
description: Patients will receive diagnostic MRI test on d8±1.
arm group label: Combined immunotherapy
arm group label: Single agent PD-1/PD-L1 inhibitor
intervention type: Radiation
intervention name: MRI test
description: Patients will receive diagnostic MRI test on d30±2.
arm group label: Combined immunotherapy
arm group label: Single agent PD-1/PD-L1 inhibitor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Lin Shen, professor
role: Principal Investigator
affiliation: Peking University
last name: Lin Shen, professor
phone: 86-10-88196561
email: linshenpku@163.com
last name: Lin Shen, MD PhD
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Shen Lin
investigator title: professor
mesh term: Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
sharing ipd: No