xml: <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/NCT06026878</url>
    </required_header>
    <id_info>
      <org_study_id>AFMMUChina</org_study_id>
      <nct_id>NCT06026878</nct_id>
    </id_info>
    <brief_title>GNT Induction Treatment in Locally Advanced NPC</brief_title>
    <official_title>Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Air Force Military Medical University, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Air Force Military Medical University, China</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare overall response rate between gemcitabine,&#xD;
        nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine&#xD;
        in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether&#xD;
        gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared&#xD;
        to GP induction chemotherapy. Participants will be randomly divided into two induction&#xD;
        treatment groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>overall response rate</measure>
      <time_frame>three weeks after induction therapy</time_frame>
      <description>the proportion of patients who achieve complete response and partial response after induction therapy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>2-year overall survival</measure>
      <time_frame>From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
      <description>2-year survival rate of patients enrolled in this study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>2-year distant metastasis-free survival</measure>
      <time_frame>From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months</time_frame>
      <description>2-year distant metastasis-free survival rate of patients enrolled in this study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>2-year local regional recurrence-free survival</measure>
      <time_frame>From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months</time_frame>
      <description>2-year local regional recurrence-free survival rate of patients enrolled in this study</description>
    </secondary_outcome>
    <other_outcome>
      <measure>adverse events</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>treatment-related adverse events during treatment and follow-up time</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">228</enrollment>
    <condition>Nasopharyngeal Carcinoma</condition>
    <arm_group>
      <arm_group_label>gemcitabine, nimotuzumab and toripalimab induction treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 every 3 weeks for two cycles.&#xD;
  nimotuzumanb 400mg every 3 weeks for two cycles. toripalimab 240mg every 3 weeks for two cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>gemcitabine and cisplatin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 and cisplatin at a dose of 80 mg per square meter on day 1 were administered intravenously once every 3 weeks for two cycles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>gemcitabine,nimotuzumab, toripalimab</intervention_name>
      <description>same as before</description>
      <arm_group_label>gemcitabine, nimotuzumab and toripalimab induction treatment</arm_group_label>
      <other_name>GNT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>gemcitabine, cisplatin</intervention_name>
      <description>same as before</description>
      <arm_group_label>gemcitabine and cisplatin</arm_group_label>
      <other_name>GP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 to 75 years old.&#xD;
  &#xD;
            2. Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing&#xD;
               squamous cell carcinoma or non-keratinizing squamous cell carcinoma.&#xD;
  &#xD;
            3. Patients suitable for radical radiochemotherapy.&#xD;
  &#xD;
            4. ECOG PS score of 0-1.&#xD;
  &#xD;
            5. According to the RECIST 1.1 criteria, there is at least one measurable lesion. Basic&#xD;
               hematological parameters are normal: white blood cell count ≥4×10^9/L; absolute&#xD;
               neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L.&#xD;
  &#xD;
            6. Basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance&#xD;
               rate (CrCl) &gt; 60 mL/min (using the Cockcroft-Gault formula): For females: CrCl =&#xD;
               (140-age) x weight (kg) x 0.85 / (72 x Scr mg/dl) For males: CrCl = (140-age) x weight&#xD;
               (kg) x 1.00 / (72 x Scr mg/dl)&#xD;
  &#xD;
            7. Basically normal liver function: serum total bilirubin ≤1.5×ULN; aspartate&#xD;
               aminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN.&#xD;
  &#xD;
            8. Signed written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who have previously undergone immunotherapy or targeted therapy.&#xD;
  &#xD;
            2. Participated in any other interventional clinical trials within 30 days before&#xD;
               screening.&#xD;
  &#xD;
            3. History of other malignancies (except for cured skin basal cell carcinoma).&#xD;
  &#xD;
            4. History of primary immunodeficiency.&#xD;
  &#xD;
            5. Presence of uncontrolled concurrent diseases (such as heart failure, severe lung&#xD;
               disease, severe liver disease, mental disease, etc.).&#xD;
  &#xD;
            6. Known HIV infection, active viral hepatitis, or tuberculosis.&#xD;
  &#xD;
            7. Major surgery within 90 days before the first dose of the study drug, or planned&#xD;
               surgery.&#xD;
  &#xD;
            8. Allergic to the drugs used in this protocol or their components.&#xD;
  &#xD;
            9. Pregnant (confirmed by blood or urine HCG tests) or breastfeeding women, or those of&#xD;
               childbearing age unwilling or unable to take effective contraceptive measures&#xD;
               (applicable to both male and female subjects) until at least 6 months after the last&#xD;
               trial treatment.&#xD;
  &#xD;
           10. The investigator believes the subject is not suitable for this study.&#xD;
  &#xD;
           11. Unwilling to participate in this study or unable to sign the informed consent form.&#xD;
  &#xD;
           12. Live vaccinations within 30 days of dosing.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mei Shi, MD</last_name>
        <phone>+86-029-84775425</phone>
        <email>mshifmmu@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Mei Shi, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jian Zang, M.D.,Ph.D</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
      <investigator_full_name>Mei Shi</investigator_full_name>
      <investigator_title>clinical professor of department of radiation oncology of XiJing hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gemcitabine</mesh_term>
      <mesh_term>Nimotuzumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026878
  org study id: AFMMUChina
  nct id: NCT06026878
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to compare overall response rate between gemcitabine,
        nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine
        in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether
        gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared
        to GP induction chemotherapy. Participants will be randomly divided into two induction
        treatment groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: overall response rate
  time frame: three weeks after induction therapy
  description: the proportion of patients who achieve complete response and partial response after induction therapy
  measure: 2-year overall survival
  time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
  description: 2-year survival rate of patients enrolled in this study
  measure: 2-year distant metastasis-free survival
  time frame: From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months
  description: 2-year distant metastasis-free survival rate of patients enrolled in this study
  measure: 2-year local regional recurrence-free survival
  time frame: From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months
  description: 2-year local regional recurrence-free survival rate of patients enrolled in this study
  measure: adverse events
  time frame: through study completion, an average of 1 year
  description: treatment-related adverse events during treatment and follow-up time
  arm group label: gemcitabine, nimotuzumab and toripalimab induction treatment
  arm group type: Experimental
  description: Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 every 3 weeks for two cycles.
  nimotuzumanb 400mg every 3 weeks for two cycles. toripalimab 240mg every 3 weeks for two cycles.
  arm group label: gemcitabine and cisplatin
  arm group type: Active Comparator
  description: Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 and cisplatin at a dose of 80 mg per square meter on day 1 were administered intravenously once every 3 weeks for two cycles.
  intervention type: Drug
  intervention name: gemcitabine,nimotuzumab, toripalimab
  description: same as before
  arm group label: gemcitabine, nimotuzumab and toripalimab induction treatment
  other name: GNT
  intervention type: Drug
  intervention name: gemcitabine, cisplatin
  description: same as before
  arm group label: gemcitabine and cisplatin
  other name: GP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Air Force Military Medical University, China
  investigator full name: Mei Shi
  investigator title: clinical professor of department of radiation oncology of XiJing hospital
  mesh term: Carcinoma
  mesh term: Nasopharyngeal Carcinoma
  mesh term: Gemcitabine
  mesh term: Nimotuzumab
  sharing ipd: No