<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/NCT04405622</url>
  </required_header>
  <id_info>
    <org_study_id>SYSUCC-CMY-2020-2104</org_study_id>
    <nct_id>NCT04405622</nct_id>
  </id_info>
  <brief_title>Toripalimab and Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma.</brief_title>
  <official_title>Toripalimab Combined With Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single center, pilot trial to evaluate the safety and efficacy of&#xD;
      toripalimab and gemcitabine in patients with recurrent or metastatic nasopharyngeal&#xD;
      carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 30, 2020</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">March 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>Adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>The safety will be assessed according to CTCAE (V5.0)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients who achieved an objective response</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients who achieved disease control</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as those with RECIST-defined objective response or stable disease according to RECIST 1.1 assessed by the investigator;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients who achieved clinical benefit</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as those with confirmed objective response or stable disease that lasted for at least 6 months;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Defined from the enrolment to RECIST defined progression or death from any causes;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as the time from first documentation of objective response to radiological disease progression.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Recurrent Nasopharyngeal Carcinoma</condition>
  <condition>Metastatic Nasopharyngeal Carcinoma</condition>
  <condition>Chemotherapy Effect</condition>
  <condition>Immunotherapy</condition>
  <arm_group>
    <arm_group_label>Toripalimab plus gemcitabin arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive gemcitabine and toripalimab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Toripalimab plus gemcitabine</intervention_name>
    <description>Subjects receive gemcitabine 1000mg/m2 (Day 1 and Day 8) and Toripalimab , 240mg, (Day 1) of each 21 days for at most 6 cycles, followed by Toripalimab 240mg every three weeks (Q3W) maintenance. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.</description>
    <arm_group_label>Toripalimab plus gemcitabin arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female; 18-70 years of age.&#xD;
&#xD;
          2. Subjects diagnosed with pathological confirmed metastatic nasopharyngeal carcinoma, or&#xD;
             subjects with recurrent NPC that is unfit for local treatment.&#xD;
&#xD;
          3. did't receive any systemic chemotherapy for recurrent and metastatic lesions.&#xD;
&#xD;
          4. Intolerance to or rejection of platinum-based chemotherapy&#xD;
&#xD;
          5. ECOG performance status of 0 or 1.&#xD;
&#xD;
          6. Life expectancy more than 12 weeks.&#xD;
&#xD;
          7. Subjects enrolled must have measurable lesion(s) according to response evaluation&#xD;
             criteria in solid (RECIST) v1.1.&#xD;
&#xD;
          8. Adequate organ function assessed by laboratory parameters during the screening period&#xD;
&#xD;
          9. Female subjects agree not to be pregnant or lactating from beginning of the study&#xD;
             screening through at least 3 months after receiving the last dose of study treatment.&#xD;
             Both men and women of reproductive potential must be willing and able to employ a&#xD;
             highly effective method of birth control/contraception to prevent pregnancy. A highly&#xD;
             effective method of contraception is defined as one that results in a low failure&#xD;
             rate, that is, less than 1% per year when used consistently and correctly&#xD;
&#xD;
         10. Able to understand and sign an informed consent form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with any active autoimmune disease or history of autoimmune disease, or&#xD;
             history of syndrome that requires systemic steroids or immunosuppressive medications,&#xD;
             including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis&#xD;
             (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and&#xD;
             hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy.&#xD;
             Subjects with the following conditions will not be excluded from this study: asthma&#xD;
             that requires intermittent use of bronchodilators, hypothyroidism stable on hormone&#xD;
             replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions&#xD;
             may be made with medical monitor approval;&#xD;
&#xD;
          2. Known history of hypersensitivity to any components of the Toripalimab formulation;&#xD;
&#xD;
          3. Concurrent medical condition requiring the use of immunosuppressive medications, or&#xD;
             immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10&#xD;
             mg/day prednisone or equivalent are prohibited within 2 weeks before study drug&#xD;
             administration. Note: corticosteroids used for the purpose of IV contrast allergy&#xD;
             prophylaxis are allowed;&#xD;
&#xD;
          4. Active central nervous system (CNS) metastases (indicated by clinical symptoms,&#xD;
             cerebral edema, steroid requirement, or progressive disease);&#xD;
&#xD;
          5. Uncontrolled clinically significant medical condition, including but not limited to&#xD;
             the following:&#xD;
&#xD;
               1. congestive heart failure (New York Health Authority Class &amp;gt; 2),&#xD;
&#xD;
               2. unstable angina,&#xD;
&#xD;
               3. myocardial infarction within the past 12 months,&#xD;
&#xD;
               4. clinically significant supraventricular arrhythmia or ventricular arrhythmia&#xD;
                  requiring treatment or intervention;&#xD;
&#xD;
          6. Active infection or an unexplained fever; 38.5°C during screening visits or on the&#xD;
             first scheduled day of dosing (at the discretion of the investigator, subjects with&#xD;
             tumor fever may be enrolled);&#xD;
&#xD;
          7. History of immunodeficiency including seropositivity for human immunodeficiency virus&#xD;
             (HIV), or other acquired or congenital immune-deficient disease;&#xD;
&#xD;
          8. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease),&#xD;
             psychiatric, or social condition deemed by the investigator to be likely to interfere&#xD;
             with a subject's rights, safety, welfare, or ability to sign informed consent,&#xD;
             cooperate, and participate in the study or would interfere with the interpretation of&#xD;
             the results; Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection&#xD;
             or risk of reactivation based on institutional guidelines and tests. Testing may&#xD;
             include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or&#xD;
             anti-Hepatitis B core antibody.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ming-Yuan Chen</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>51006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Ming-Yuan Chen</investigator_full_name>
    <investigator_title>Chief physician, Proffessor</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>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_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/NCT04405622
org study id: SYSUCC-CMY-2020-2104
nct id: NCT04405622
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an open-label, single center, pilot trial to evaluate the safety and efficacy of
      toripalimab and gemcitabine in patients with recurrent or metastatic nasopharyngeal
      carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events
time frame: 1 year
description: The safety will be assessed according to CTCAE (V5.0)
measure: The proportion of patients who achieved an objective response
time frame: 1 year
description: Defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;
measure: The proportion of patients who achieved disease control
time frame: 1 year
description: Defined as those with RECIST-defined objective response or stable disease according to RECIST 1.1 assessed by the investigator;
measure: The proportion of patients who achieved clinical benefit
time frame: 1 year
description: Defined as those with confirmed objective response or stable disease that lasted for at least 6 months;
measure: Progression-free survival
time frame: 1 year
description: Defined from the enrolment to RECIST defined progression or death from any causes;
measure: Duration of response
time frame: 1 year
description: Defined as the time from first documentation of objective response to radiological disease progression.
arm group label: Toripalimab plus gemcitabin arm
arm group type: Experimental
description: Subjects receive gemcitabine and toripalimab.
intervention type: Drug
intervention name: Toripalimab plus gemcitabine
description: Subjects receive gemcitabine 1000mg/m2 (Day 1 and Day 8) and Toripalimab , 240mg, (Day 1) of each 21 days for at most 6 cycles, followed by Toripalimab 240mg every three weeks (Q3W) maintenance. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.
arm group label: Toripalimab plus gemcitabin arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Ming-Yuan Chen
investigator title: Chief physician, Proffessor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Recurrence
mesh term: Gemcitabine