<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/NCT04412408</url>
  </required_header>
  <id_info>
    <org_study_id>SCMC-Sintilimab-2020</org_study_id>
    <nct_id>NCT04412408</nct_id>
  </id_info>
  <brief_title>Study on Sintilimab in Stage IV High Risk Neuroblastoma</brief_title>
  <acronym>SCMC-S-2020</acronym>
  <official_title>Clinical Study on the Treatment of Recurrent Stage IV High Risk Neuroblastoma With Sintilimab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Children's Medical Center</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>
      A phase I observational study on the safety and efficacy of treatment of recurrent stage IV&#xD;
      high risk neuroblastoma with Nivolumab&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response</measure>
    <time_frame>2 years after taking the drug</time_frame>
    <description>Complete response: (CR): the tumor shrunk more than 50%.&#xD;
Part of the reaction: (PR): the reduction of tumor body was more than 30%.&#xD;
No response: (NP): the tumor decreased by less than 30% or increased.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effect</measure>
    <time_frame>2 years after taking the drug</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mutation</measure>
    <time_frame>before taking the drug</time_frame>
    <description>Mutation load, high microsatellite instability (MSI-H) or mismatch repair defect (dMMR)</description>
  </other_outcome>
  <other_outcome>
    <measure>programmed death-ligand1 (PD-L1) expression</measure>
    <time_frame>before taking the drug</time_frame>
    <description>immunohistochemistry (IHC) test for PD-L1 and cluster of differentiation 8 (CD8) expression in tumor tissue</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Recurrent Stage IV High Risk Neuroblastoma</condition>
  <arm_group>
    <arm_group_label>Sintilimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.&#xD;
Dose: 2 mg / kg intravenously for 60 min (± 10 min window)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sintilimab</intervention_name>
    <description>Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.&#xD;
Dose: 2 mg / kg intravenously for 60 min (± 10 min window)</description>
    <arm_group_label>Sintilimab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 12 Months to 12 years&#xD;
&#xD;
          2. Histologic verification of stage IV high risk neuroblastoma at relapse following lack&#xD;
             of complete response to at least two lines of therapy&#xD;
&#xD;
          3. Fully recovered from the acute toxic effects of all prior anti-cancer treatment&#xD;
&#xD;
          4. At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if&#xD;
             prior nitrosourea)&#xD;
&#xD;
          5. At least 42 days after the completion of any type of immunotherapy, e.g. tumor&#xD;
             vaccines&#xD;
&#xD;
          6. At least 56 days must have elapsed after transplant or stem cell infusion; patients&#xD;
             with prior allogeneic transplants are not eligible&#xD;
&#xD;
          7. Blood counts recovery including White cell count &gt;= 750/mm^3 and Platelet count &gt;=&#xD;
             50,000/mm^3&#xD;
&#xD;
          8. Creatinine clearance ≥ 50ml/min&#xD;
&#xD;
          9. Liver function: Total bilirubin ≤ 2 mg/dl, Alanine aminotransferase or Aspartate&#xD;
             aminotransferase ≤ 2.5 U/dl (or &lt; 5 in case of liver impairment)&#xD;
&#xD;
         10. Life expectancy of at least 4 months&#xD;
&#xD;
         11. Negative pregnancy test in women of childbearing potential&#xD;
&#xD;
         12. Use of an effective contraceptive method during the whole treatment and&#xD;
&#xD;
         13. up to 3 months after the completion of treatment in males and females&#xD;
&#xD;
         14. Prior informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients requiring daily systemic corticosteroids are not eligible; patients must not&#xD;
             have received systemic corticosteroids within 7 days of enrollment on study&#xD;
&#xD;
          2. Patients who are currently receiving another investigational drug are not eligible&#xD;
&#xD;
          3. Patients who are currently receiving other anti-cancer agents are not eligible&#xD;
&#xD;
          4. Patients with a history of any grade autoimmune disorder are not eligible;&#xD;
             asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ANA), rheumatoid&#xD;
             factor, altered thyroid function studies) will not render a patient ineligible in the&#xD;
             absence of a diagnosis of an autoimmune disorder&#xD;
&#xD;
          5. Patients with &gt;= grade 2 hypothyroidism due to history of autoimmunity are not&#xD;
             eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not&#xD;
             impact eligibility&#xD;
&#xD;
          6. Patients who have an uncontrolled infection are not eligible.&#xD;
&#xD;
          7. Patients with active autoimmune disease. (any autoimmune state requiring medical&#xD;
             treatment-including chronic medications)all immune modifying drugs should be stopped&#xD;
             at least 7 days prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Xu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Children's Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Song Gu, MD</last_name>
    <phone>18930830716</phone>
    <email>gusong@shsmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Song Gu, Doctor</last_name>
      <phone>18930830716</phone>
      <email>gusong@shsmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 8, 2020</last_update_submitted>
  <last_update_submitted_qc>August 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroblastoma</mesh_term>
  </condition_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/NCT04412408
org study id: SCMC-Sintilimab-2020
nct id: NCT04412408
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A phase I observational study on the safety and efficacy of treatment of recurrent stage IV
      high risk neuroblastoma with Nivolumab
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: response
time frame: 2 years after taking the drug
description: Complete response: (CR): the tumor shrunk more than 50%.
Part of the reaction: (PR): the reduction of tumor body was more than 30%.
No response: (NP): the tumor decreased by less than 30% or increased.
measure: side effect
time frame: 2 years after taking the drug
description: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
measure: Mutation
time frame: before taking the drug
description: Mutation load, high microsatellite instability (MSI-H) or mismatch repair defect (dMMR)
measure: programmed death-ligand1 (PD-L1) expression
time frame: before taking the drug
description: immunohistochemistry (IHC) test for PD-L1 and cluster of differentiation 8 (CD8) expression in tumor tissue
arm group label: Sintilimab
arm group type: Experimental
description: Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.
Dose: 2 mg / kg intravenously for 60 min (± 10 min window)
intervention type: Drug
intervention name: Sintilimab
description: Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.
Dose: 2 mg / kg intravenously for 60 min (± 10 min window)
arm group label: Sintilimab
criteria: 
gender: All
minimum age: 12 Months
maximum age: 12 Years
healthy volunteers: No
last name: Min Xu, MD
role: Principal Investigator
affiliation: Shanghai Children's Medical Center
last name: Song Gu, MD
phone: 18930830716
email: gusong@shsmu.edu.cn
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Neuroblastoma