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/NCT06036745</url>
    </required_header>
    <id_info>
      <org_study_id>K</org_study_id>
      <nct_id>NCT06036745</nct_id>
    </id_info>
    <brief_title>Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen</brief_title>
    <official_title>An Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination With SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Minimally Invasive Surgery Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Minimally Invasive Surgery Center</source>
    <oversight_info>
      <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>
        it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with&#xD;
        SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">July 1, 2026</completion_date>
    <primary_completion_date type="Actual">July 1, 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>Disease-free survival</measure>
      <time_frame>3 years</time_frame>
      <description>the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>3 years</time_frame>
      <description>the time from the start of surgery to death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>perioperative complications</measure>
      <time_frame>the time from the start of enrollment to 3 months after surgery</time_frame>
      <description>perioperative complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery</time_frame>
      <description>occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Gastric Cancer Stage IIIB-IIIC</condition>
    <arm_group>
      <arm_group_label>Pembrolizumab + SOX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab + SOX</intervention_name>
      <description>Pembrolizumab 200mg, ivdrip, q3w; Oxaliplatin 135mg/m2, ivdrip，q3w; Trastuzumab 40 mg/m2，po bid，d1~d14，q21d. Each cycle consists of three weeks, totaling eight cycles</description>
      <arm_group_label>Pembrolizumab + SOX</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Subjects voluntarily join the study and sign an informed consent form; 2. Male or&#xD;
               female patients between the ages of 18-75; 3. Adenocarcinoma of the&#xD;
               gastric/esophagogastric junction after radical resection was staged at stage&#xD;
               IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the&#xD;
               following three conditions:&#xD;
  &#xD;
                 1. Consistent with high-frequency microsatellite instability MSI-H&#xD;
  &#xD;
                 2. Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases)&#xD;
  &#xD;
                 3. High expression of PD-L1 (CPS score ≥5) 5. Expected survival time &gt; 6 months； 6.&#xD;
                    ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; 7. Have not&#xD;
                    received anti-tumor immunotherapy; 8. Agree to provide archived tumor tissue&#xD;
                    samples for molecular testing; 9. Have good organ function:&#xD;
  &#xD;
                 1. Hemoglobin ≥90g/L;&#xD;
  &#xD;
                 2. Absolute neutrophil count ≥1.5×109/ L;&#xD;
  &#xD;
                 3. Platelet count ≥100×109/ L;&#xD;
  &#xD;
                 4. aspartate or alanine aminotransferase ≤ 2.5 times the upper limit;&#xD;
  &#xD;
                 5. alkaline phosphatase ≤ 2.5 times the upper normal limit ; 10. Women of&#xD;
                    reproductive age who need to use a medically approved contraceptive method (such&#xD;
                    as an IUD, contraceptive pill, or condom) during the study treatment period and&#xD;
                    for 3 months after the end of the study treatment period; For men who agreed to&#xD;
                    use an appropriate method of contraception during the trial and for 3 months&#xD;
                    after the last dose of the trial drug.&#xD;
  &#xD;
                    11. Women of reproductive age must be negative for serum or urine HCG within 72&#xD;
                    hours prior to study entry. And must be non-lactating.&#xD;
  &#xD;
                    Exclusion Criteria:&#xD;
  &#xD;
                 1. Patients with severe hypertension and poor drug control;&#xD;
  &#xD;
                 2. Patients with difficulty in taking oral drugs due to dysphagia, complete or&#xD;
                    incomplete digestive tract obstruction, active gastrointestinal bleeding,&#xD;
                    perforation, etc.;&#xD;
  &#xD;
                 3. People who are known to be allergic to the ingredients in the test drug or have&#xD;
                    metabolic disorders;&#xD;
  &#xD;
                 4. Simultaneously participating in other tumor experimental drugs or being in other&#xD;
                    tumor clinical trials.&#xD;
  &#xD;
                 5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory&#xD;
                    disease or uncontrollable diabetes, hypertension and other chronic system&#xD;
                    diseases; Clinically obvious heart disease, such as congestive heart failure,&#xD;
                    obvious coronary heart disease, medically difficult to control arrhythmia,&#xD;
                    hypertension, or myocardial infarction within 6 months, or cardiac insufficiency;&#xD;
  &#xD;
                 6. Patients with peripheral nervous system disorders or a history of obvious mental&#xD;
                    disorders and central nervous system disorders;&#xD;
  &#xD;
                 7. Diagnosed with immunodeficiency or received systemic hormone therapy or other&#xD;
                    forms of immunosuppressive therapy within 7 days prior to initial administration;&#xD;
  &#xD;
                 8. Active period &amp;gt; CTCAE (Version 5.0) grade 2 clinical severe infection;&#xD;
  &#xD;
                 9. Pregnant and lactating women, women of childbearing age and their spouses refuse&#xD;
                    to take effective contraceptive methods;&#xD;
  &#xD;
                10. Persons without legal capacity, whose medical or ethical reasons affect the&#xD;
                    continuation of the research.&#xD;
  &#xD;
                11. Other conditions determined by the investigator to be unsuitable for inclusion in&#xD;
                    the study.&#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>Zhenghao Cai</last_name>
      <phone>17316533505</phone>
      <email>c3z2h1@alumni.sjtu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ruijin Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>CAI Zhenghao</last_name>
        <phone>17316533505</phone>
        <email>c3z2h1@alumni.sjtu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pembrolizumab</mesh_term>
    </intervention_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/NCT06036745
  org study id: K
  nct id: NCT06036745
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with
        SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Disease-free survival
  time frame: 3 years
  description: the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.
  measure: Overall survival
  time frame: 3 years
  description: the time from the start of surgery to death due to any cause.
  measure: perioperative complications
  time frame: the time from the start of enrollment to 3 months after surgery
  description: perioperative complications
  measure: Adverse Events
  time frame: the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery
  description: occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment.
  arm group label: Pembrolizumab + SOX
  arm group type: Experimental
  intervention type: Drug
  intervention name: Pembrolizumab + SOX
  description: Pembrolizumab 200mg, ivdrip, q3w; Oxaliplatin 135mg/m2, ivdrip，q3w; Trastuzumab 40 mg/m2，po bid，d1~d14，q21d. Each cycle consists of three weeks, totaling eight cycles
  arm group label: Pembrolizumab + SOX
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zhenghao Cai
  phone: 17316533505
  email: c3z2h1@alumni.sjtu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms
  mesh term: Pembrolizumab