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/NCT05981157</url>
    </required_header>
    <id_info>
      <org_study_id>ZSCPH-001</org_study_id>
      <nct_id>NCT05981157</nct_id>
    </id_info>
    <brief_title>Anrotinib and Tirelizumab in First-line Treatment of RM-NPC</brief_title>
    <official_title>Anrotinib Combined With Tirelizumab in First-line Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongshan People's Hospital, Guangdong, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongshan People's Hospital, Guangdong, 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>
        This is a prospective phase II clinical trial to evaluate the efficacy and safety of&#xD;
        Anrotinib and Tirelizumab as a first-line treatment in patients with advanced recurrent or&#xD;
        metastatic nasopharyngeal carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2025</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>Objective response rate</measure>
      <time_frame>1 year</time_frame>
      <description>Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The proportion of patients who achieved disease control</measure>
      <time_frame>1 year</time_frame>
      <description>Defined as the proportion of subjects who achieve CR+PR+stable disease (SD) for at least 4 weeks according to RECIST 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of patients who achieved clinical benefit</measure>
      <time_frame>1 year</time_frame>
      <description>Defined as maintaining the efficacy of CR+PR+SD for at least 6 months according to RECIST 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>1 year</time_frame>
      <description>Defined as the time from the first assessment of CR and PR to the first assessment of PD or death caused by any cause according to RECIST 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>progression-free survival</measure>
      <time_frame>1 year</time_frame>
      <description>Defined as the period from the start of enrollment until disease progression or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>1 year</time_frame>
      <description>NCI-CTC5.0 standard was adopted, and the safety was assessed mainly by clinical laboratory tests, ECOG-PS score, physical examination, electrocardiogram, and adverse event results.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">27</enrollment>
    <condition>Nasopharyngeal Carcinoma</condition>
    <arm_group>
      <arm_group_label>Anrotinib plus Tirelizumab arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects receive anrotinib plus tirelizumab</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anrotinib plus Tirelizumab</intervention_name>
      <description>Subjects receive Anrotinib, 10mg, QD and Tirelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.</description>
      <arm_group_label>Anrotinib plus Tirelizumab arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th;&#xD;
               the metastatic tissue biopsy is preferred, not necessary; locoregional recurrent&#xD;
               lesion unfit for local treatment).&#xD;
  &#xD;
            2. Subjects enrolled must have measurable lesion(s) according to response evaluation&#xD;
               criteria in solid (RECIST) v1.1.&#xD;
  &#xD;
            3. ECOG performance status of 0～2&#xD;
  &#xD;
            4. Life expectancy more than 12 weeks.&#xD;
  &#xD;
            5. unable or unwilling to undergo chemothraphy&#xD;
  &#xD;
            6. Able to understand and sign an informed consent form (ICF).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Uncontrolled clinically significant medical condition, including but not limited to&#xD;
               the following: Hypertension that cannot be reduced to the normal range after&#xD;
               antihypertensive drug congestive heart failure (New York Health Authority Class &amp;gt;&#xD;
               2), unstable angina, myocardial infarction within the past 12 months, clinically&#xD;
               significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment&#xD;
               or intervention;&#xD;
  &#xD;
            2. Known history of hypersensitivity to any components of the Tirelizumab formulation or&#xD;
               other monoclonal antibodies ;&#xD;
  &#xD;
            3. Diagnosed with other malignant tumors.&#xD;
  &#xD;
            4. 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;
            5. Subjects with medical condition affecting oral drug absorption, such as dysphagia,&#xD;
               chronic diarrhea and intestinal obstruction.&#xD;
  &#xD;
            6. Active bleeding, ulcer, intestinal perforation, major surgery in the previous month;&#xD;
               Patients with tumors close to the internal carotid artery or other large vessels, thus&#xD;
               at risk of massive bleeding.&#xD;
  &#xD;
            7. The laboratory test values within 7 days before enrollment do not meet the relevant&#xD;
               standards.&#xD;
  &#xD;
            8. 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 4 weeks before study drug&#xD;
               administration. Note: corticosteroids used for the purpose of IV contrast allergy&#xD;
               prophylaxis are allowed;&#xD;
  &#xD;
            9. History of immunodeficiency including seropositivity for human immunodeficiency virus&#xD;
               (HIV), or other acquired or congenital immune-deficient disease; active tuberculosis&#xD;
               (TB), anti-TB treatment is ongoing or within 1 year prior to screening; Evidence of&#xD;
               hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation&#xD;
               based on institutional guidelines and tests. Testing may include the following: HBV&#xD;
               DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.&#xD;
  &#xD;
           10. Subjects with comorbidities with long-term immunosuppressive drug therapy, or with&#xD;
               systemic or local use of immunosuppressive doses of corticosteroids.&#xD;
  &#xD;
           11. Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any other&#xD;
               antibody acting on T cell synergistic stimulation or checkpoint pathway) and&#xD;
               anti-angiogenic drugs.&#xD;
  &#xD;
           12. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.)&#xD;
               within 4 weeks prior to enrollment.&#xD;
  &#xD;
           13. 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;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Guiqiong Xu, MD</last_name>
      <phone>+8613528109888</phone>
      <email>donna_shee@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhongshan City People's Hospital</name>
        <address>
          <city>Zhongshan</city>
          <state>Guangdong</state>
          <zip>528403</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guiqiong Xu</last_name>
        <phone>+8613528109888</phone>
        <email>donna_shee@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongshan People's Hospital, Guangdong, China</investigator_affiliation>
      <investigator_full_name>Gui-Qiong Xu</investigator_full_name>
      <investigator_title>Deputy director of Radiotherapy department for Nasopharyngeal and Head and Neck Tumors</investigator_title>
    </responsible_party>
    <keyword>nasopharyngeal carcinoma</keyword>
    <keyword>Immunotherapy</keyword>
    <keyword>Molecular Targeted Therapy</keyword>
    <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>
    <!-- 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/NCT05981157
  org study id: ZSCPH-001
  nct id: NCT05981157
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a prospective phase II clinical trial to evaluate the efficacy and safety of
        Anrotinib and Tirelizumab as a first-line treatment in patients with advanced recurrent or
        metastatic nasopharyngeal carcinoma.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate
  time frame: 1 year
  description: Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1
  measure: The proportion of patients who achieved disease control
  time frame: 1 year
  description: Defined as the proportion of subjects who achieve CR+PR+stable disease (SD) for at least 4 weeks according to RECIST 1.1.
  measure: The proportion of patients who achieved clinical benefit
  time frame: 1 year
  description: Defined as maintaining the efficacy of CR+PR+SD for at least 6 months according to RECIST 1.1.
  measure: Duration of response
  time frame: 1 year
  description: Defined as the time from the first assessment of CR and PR to the first assessment of PD or death caused by any cause according to RECIST 1.1.
  measure: progression-free survival
  time frame: 1 year
  description: Defined as the period from the start of enrollment until disease progression or death from any cause.
  measure: Adverse events
  time frame: 1 year
  description: NCI-CTC5.0 standard was adopted, and the safety was assessed mainly by clinical laboratory tests, ECOG-PS score, physical examination, electrocardiogram, and adverse event results.
  arm group label: Anrotinib plus Tirelizumab arm
  arm group type: Experimental
  description: Subjects receive anrotinib plus tirelizumab
  intervention type: Drug
  intervention name: Anrotinib plus Tirelizumab
  description: Subjects receive Anrotinib, 10mg, QD and Tirelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.
  arm group label: Anrotinib plus Tirelizumab arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Guiqiong Xu, MD
  phone: +8613528109888
  email: donna_shee@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongshan People's Hospital, Guangdong, China
  investigator full name: Gui-Qiong Xu
  investigator title: Deputy director of Radiotherapy department for Nasopharyngeal and Head and Neck Tumors
  mesh term: Carcinoma
  mesh term: Nasopharyngeal Carcinoma