<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/NCT04421469</url>
  </required_header>
  <id_info>
    <org_study_id>NPC005.1</org_study_id>
    <nct_id>NCT04421469</nct_id>
  </id_info>
  <brief_title>Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC</brief_title>
  <official_title>A Single-arm, Open Multicenter Phase II Clinical Study of Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangxi Provincial Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fujian Cancer 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>
      This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the&#xD;
      efficacy and tolerability of JS001 and chemotherapy combined with local treatment in patients&#xD;
      with multiple metastatic nasopharyngeal carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 15, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2023</primary_completion_date>
  <phase>Phase 2</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>Progression-Free Survival(PFS)</measure>
    <time_frame>2 year</time_frame>
    <description>PFS was defined as the time from diagnosis of metastasis to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>2 year</time_frame>
    <description>Objective response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>2 year</time_frame>
    <description>Disease contral rate</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Comprehensive treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triprilimab(JS001)</intervention_name>
    <description>JS001 240mg d1, gemcitabine(1g/m²),d1,8 + nedaplatin (80-100mg/m²),d2,q3w,6cycles.The curative effect was evaluated every 2 cycles.If the therapeutic evaluation was SD,the chemotherapy scheme was changed;&#xD;
Local treatment of active lesions(including radiotherapy and/or radiofrequency ablation);&#xD;
JS001 maintenance treatment.</description>
    <arm_group_label>Comprehensive treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with multiple metastases at first diagnosis or multiple metastases after&#xD;
             treatment(multiple metastases was defined as more than 5 lesions and/or more than 2&#xD;
             metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry,&#xD;
             and life expectancy ≥6months as judged by the Investigator;&#xD;
&#xD;
          3. The disease must be measurable with at least 1 unidimensional measurable lesion by&#xD;
             Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;&#xD;
&#xD;
          4. Adequate organ function;&#xD;
&#xD;
          5. Take adequate contraceptive measures throughout the study, and contraception continues&#xD;
             until 12 months after treatment;&#xD;
&#xD;
          6. Able and willing to provide signed informed consent form, and able to comply with all&#xD;
             procedures.&#xD;
&#xD;
          7. The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6&#xD;
             months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a hypersensitivity to any of the drugs used in our study;&#xD;
&#xD;
          2. With any active autoimmune disease or history of autoimmune disease;&#xD;
&#xD;
          3. Clinically significant cardiovascular and cerebrovascular diseases;&#xD;
&#xD;
          4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma&#xD;
             skin cancer or pre-invasive cervical cancer);&#xD;
&#xD;
          5. Active systemic infection;&#xD;
&#xD;
          6. Drug or alcohol abuse;&#xD;
&#xD;
          7. No or limited capacity for civil conduct;&#xD;
&#xD;
          8. The patient has a physical or mental disorder, and the researcher considers that the&#xD;
             patient is unable to fully or fully understand the possible complications of this&#xD;
             study;&#xD;
&#xD;
          9. History of immunodeficiency including seropositive for human immunodeficiency virus&#xD;
             (HIV), or other acquired or congenital immune-deficient disease, or any active&#xD;
             systemic viral infection requiring therapy；&#xD;
&#xD;
         10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before&#xD;
             the study treatment, and subject requiring hormone therapy during trials.&#xD;
&#xD;
         11. Pregnancy or breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shaojun Lin, DR</last_name>
    <phone>13860603879</phone>
    <email>linshaojun@yeah.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qiaojuan Guo, DR</last_name>
    <phone>15080013157</phone>
    <email>guoqiaojuan@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of radiation oncology, Fujian cancer hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Shaojun Lin, DR</last_name>
      <phone>0591-62752225</phone>
      <email>linshaojun@yeah.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 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>Nasopharyngeal Carcinoma</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/NCT04421469
org study id: NPC005.1
nct id: NCT04421469
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the
      efficacy and tolerability of JS001 and chemotherapy combined with local treatment in patients
      with multiple metastatic nasopharyngeal carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival(PFS)
time frame: 2 year
description: PFS was defined as the time from diagnosis of metastasis to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
measure: ORR
time frame: 2 year
description: Objective response rate
measure: DCR
time frame: 2 year
description: Disease contral rate
arm group label: Comprehensive treatment
arm group type: Experimental
description: Patients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment.
intervention type: Drug
intervention name: Triprilimab(JS001)
description: JS001 240mg d1, gemcitabine(1g/m²),d1,8 + nedaplatin (80-100mg/m²),d2,q3w,6cycles.The curative effect was evaluated every 2 cycles.If the therapeutic evaluation was SD,the chemotherapy scheme was changed;
Local treatment of active lesions(including radiotherapy and/or radiofrequency ablation);
JS001 maintenance treatment.
arm group label: Comprehensive treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shaojun Lin, DR
phone: 13860603879
email: linshaojun@yeah.net
last name: Qiaojuan Guo, DR
phone: 15080013157
email: guoqiaojuan@163.com
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Nasopharyngeal Carcinoma