<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/NCT04430166</url>
  </required_header>
  <id_info>
    <org_study_id>2019KT1192</org_study_id>
    <nct_id>NCT04430166</nct_id>
  </id_info>
  <brief_title>PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma</brief_title>
  <official_title>A Exploratory Clinical Study on PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou University of Traditional Chinese Medicine</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>
      Lymphoepithelioma-like carcinoma (LELC) may benefit from immunocheckpoint inhibitor therapy.&#xD;
      Although target antibody drugs for PD-1 and PD-L1 have achieved good results in immunotherapy&#xD;
      of many malignant tumors, there is still a lack of corresponding clinical research reports on&#xD;
      whether LELC treatment can benefit. Therefore, this study intends to adopt the basket&#xD;
      research model , to explore the application of anti-procedural death receptor 1 (PD-1)&#xD;
      monoclonal antibody in patients with advanced LELC after the failure of first-line standard&#xD;
      treatment . Further explore the relationship between tumor and body immunity, tumor&#xD;
      microenvironment and curative effect, and find stable biomarkers, so as to screen out the&#xD;
      superior population of tumor immunotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <phase>N/A</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>Progress-free survival</measure>
    <time_frame>Through study completion, an average of 9 weeks</time_frame>
    <description>The time from enrollment to the occurrence of tumor development (in any aspect) or death (for any reason).&#xD;
For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship. Subjects who did not undergo imaging evaluation or no death record after baseline were deleted based on the enrollment date.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>Through study completion，an average of 9 weeks</time_frame>
    <description>According to the RECIST 1.1 standard, the proportion of subjects with complete response(CR) or partial response(PR) in the analysis population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to initial response</measure>
    <time_frame>Through study completion，an average of 9 weeks</time_frame>
    <description>The time from enrollment to the first objective response (CR or PR) of the tumor.&#xD;
For subjects who did not reach CR or PR, the date of the last imaging evaluation was the date of censorship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Through study completion， an average of 90 days</time_frame>
    <description>The time from enrollment to (for any reason) death. At the end of the study, if the subject is still alive, the known date of the subject's last survival&quot; will be the censored date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Through study completion，an average of 9 weeks</time_frame>
    <description>The time from the first recorded objective tumor response (CR or PR) to objective disease progression (PD) or death.&#xD;
For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor immune microenvironment</measure>
    <time_frame>Baseline</time_frame>
    <description>immune microenvironment state of tumor tissue will be detected by Opal multiplex immunofluorescence assay</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Lymphoepithelioma-Like Carcinoma</condition>
  <arm_group>
    <arm_group_label>PD-1 monoclonal antibody</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PD-1 monoclonal antibody</intervention_name>
    <description>200mg / intravenous drip, once every three weeks</description>
    <arm_group_label>PD-1 monoclonal antibody</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological diagnosis of lymphoepithelioma-like carcinoma&#xD;
&#xD;
          -  Failed the first-line standard treatment or progressed after the treatment, at least&#xD;
             one measurable lesion according to the RECIST1.1 standard&#xD;
&#xD;
          -  Age between 18 and 80 years old&#xD;
&#xD;
          -  Estimated life expectancy exceeds 3 months&#xD;
&#xD;
          -  ECOG Performance Status score ≤ 2&#xD;
&#xD;
          -  Normal bone marrow, liver, kidney, clotting function, including： hemoglobin ≥90g/L (no&#xD;
             history of blood transfusion within 7 days), absolute neutrophil count ≥1.5×109/L,&#xD;
             platelet ≥100×109/L, total bilirubin ≤1.5×ULN, albumin ≥30g/ L, aspartate&#xD;
             aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of&#xD;
             normal (ULN), if combined with liver metastases, AST and ALT ≤ 5 × ULN; creatinine ≤&#xD;
             1.5 × ULN; international standardized ratio (INR) or coagulation Proenzyme time (PT) ≤&#xD;
             1.5 × ULN, if the subject receives anticoagulant therapy normally, as long as the PT&#xD;
             is within the range planned by the anticoagulant drug&#xD;
&#xD;
          -  Women of childbearing age should have a urine or serum pregnancy test negative within&#xD;
             3 days before receiving the first study drug administration. If the urine pregnancy&#xD;
             test result cannot be confirmed negative, a blood pregnancy test is required&#xD;
&#xD;
          -  Ensure effective contraception during the study period and at least 6 months after the&#xD;
             study ended.&#xD;
&#xD;
          -  Sign an informed consent form and follow up with good compliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Merging other pathological tumors&#xD;
&#xD;
          -  Active bleeding, active diverticulitis, abdominal abscess, gastrointestinal&#xD;
             perforation, gastrointestinal obstruction, and peritoneal metastasis that require&#xD;
             clinical intervention; clinically uncontrollable pleural, abdominal, and pericardial&#xD;
             effusions (drainage effusions are not required or patients who have stopped draining&#xD;
             for 3 days without a significant increase in effusion can be enrolled); severe&#xD;
             bleeding tendency or coagulopathy；receiving thrombolytic therap&#xD;
&#xD;
          -  Uncontrolled hypertension（systolic blood pressure &gt;140 mmHg or diastolic blood&#xD;
             pressure &gt;90 mmHg after optimal medical treatment）；history of hypertension crisis or&#xD;
             hypertensive encephalopathy&#xD;
&#xD;
          -  History of organ transplantation (including autologous bone marrow transplantation and&#xD;
             peripheral stem cell transplantation)&#xD;
&#xD;
          -  Grade III-IV congestive heart failure (according to New York Heart Association&#xD;
             classification), poorly controlled and clinically significant&#xD;
&#xD;
          -  Any arterial, venous thrombosis, embolism, or ischemia occurred within 6 months before&#xD;
             enrolling in the treatment&#xD;
&#xD;
          -  Central nervous system metastasis&#xD;
&#xD;
          -  Active infection that requires treatment, or systemic anti-infective drugs have been&#xD;
             used within one week before the first dose; or there is active tuberculosis (TB),&#xD;
             normal anti-TB treatment or anti-TB within 1 year before the first dose treatment&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection (ie HIV1/2 antibody&#xD;
             positive), known syphilis infection&#xD;
&#xD;
          -  Acute or chronic active hepatitis B or hepatitis C infection, including hepatitis B&#xD;
             virus (HBV) DNA&gt;2000IU/ml or 104 copies/ml，hepatitis C virus (HCV) RNA&gt;103 copies/ml&#xD;
             or HBsAg Positive simultaneously with anti-HCV antibody&#xD;
&#xD;
          -  Active autoimmune diseases requiring systemic treatment occurred within 2 years before&#xD;
             the first dose(alternative therapies such as thyroxine, insulin, or physiological&#xD;
             doses of corticosteroids used for adrenal or pituitary insufficiency are not&#xD;
             considered systemic treatment）&#xD;
&#xD;
          -  History of non-infectious pneumonia requiring corticosteroid therapy or current&#xD;
             pneumonia within 1 year before the first dose（patients with intermittent use of&#xD;
             bronchodilators, inhaled corticosteroids, or local injection of corticosteroids due to&#xD;
             COPD and asthma can be enrolled）&#xD;
&#xD;
          -  Previously received immunotherapy treatment, or received immunomodulatory drug&#xD;
             treatment within 2 weeks before the first dose, or received major surgical treatment&#xD;
             within 3 weeks before the first dose&#xD;
&#xD;
          -  Known to have an allergic reaction to the active ingredient of PD-1 monoclonal&#xD;
             antibody and/or any excipients&#xD;
&#xD;
          -  Mental illnesses or drug abuse that may affect compliance with research requirements&#xD;
&#xD;
          -  Currently participating in interventional clinical research treatment, or receiving&#xD;
             other research drugs or research equipment within 4 weeks before the first dose&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Other acute, chronic and mental diseases that may lead to the following results:&#xD;
             laboratory test values are abnormal；increase the risk of research participation or&#xD;
             study drug administration； interfere with the interpretation of the study 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>Lirong Liu, MM</last_name>
    <phone>86 20 81887233</phone>
    <phone_ext>34830</phone_ext>
    <email>doctorllr@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhenzhen Xiao, MM</last_name>
    <phone>86 20 81887233</phone>
    <phone_ext>34830</phone_ext>
    <email>768197690@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Lirong Liu, MM</last_name>
      <phone>86 20 81887233</phone>
      <phone_ext>34830</phone_ext>
      <email>doctorllr@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhenzhen Xiao, MM</last_name>
      <phone>86 20 81887233</phone>
      <phone_ext>34830</phone_ext>
      <email>768197690@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Haibo Zhang, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Haibo Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Lymphoepithelioma-like carcinoma</keyword>
  <keyword>PD-1 monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04430166
org study id: 2019KT1192
nct id: NCT04430166
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lymphoepithelioma-like carcinoma (LELC) may benefit from immunocheckpoint inhibitor therapy.
      Although target antibody drugs for PD-1 and PD-L1 have achieved good results in immunotherapy
      of many malignant tumors, there is still a lack of corresponding clinical research reports on
      whether LELC treatment can benefit. Therefore, this study intends to adopt the basket
      research model , to explore the application of anti-procedural death receptor 1 (PD-1)
      monoclonal antibody in patients with advanced LELC after the failure of first-line standard
      treatment . Further explore the relationship between tumor and body immunity, tumor
      microenvironment and curative effect, and find stable biomarkers, so as to screen out the
      superior population of tumor immunotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress-free survival
time frame: Through study completion, an average of 9 weeks
description: The time from enrollment to the occurrence of tumor development (in any aspect) or death (for any reason).
For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship. Subjects who did not undergo imaging evaluation or no death record after baseline were deleted based on the enrollment date.
measure: Objective response rate
time frame: Through study completion，an average of 9 weeks
description: According to the RECIST 1.1 standard, the proportion of subjects with complete response(CR) or partial response(PR) in the analysis population.
measure: Time to initial response
time frame: Through study completion，an average of 9 weeks
description: The time from enrollment to the first objective response (CR or PR) of the tumor.
For subjects who did not reach CR or PR, the date of the last imaging evaluation was the date of censorship.
measure: Overall survival
time frame: Through study completion， an average of 90 days
description: The time from enrollment to (for any reason) death. At the end of the study, if the subject is still alive, the known date of the subject's last survival" will be the censored date.
measure: Duration of response
time frame: Through study completion，an average of 9 weeks
description: The time from the first recorded objective tumor response (CR or PR) to objective disease progression (PD) or death.
For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship.
measure: Tumor immune microenvironment
time frame: Baseline
description: immune microenvironment state of tumor tissue will be detected by Opal multiplex immunofluorescence assay
arm group label: PD-1 monoclonal antibody
arm group type: Experimental
intervention type: Drug
intervention name: PD-1 monoclonal antibody
description: 200mg / intravenous drip, once every three weeks
arm group label: PD-1 monoclonal antibody
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lirong Liu, MM
phone: 86 20 81887233
phone ext: 34830
email: doctorllr@163.com
last name: Zhenzhen Xiao, MM
phone: 86 20 81887233
phone ext: 34830
email: 768197690@qq.com
facility: 
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou University of Traditional Chinese Medicine
investigator full name: Haibo Zhang
investigator title: Professor
mesh term: Carcinoma
mesh term: Antibodies
mesh term: Antibodies, Monoclonal
sharing ipd: No