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/NCT05975749</url>
    </required_header>
    <id_info>
      <org_study_id>GC-her2</org_study_id>
      <nct_id>NCT05975749</nct_id>
    </id_info>
    <brief_title>Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer</brief_title>
    <official_title>A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to find out whether treatment with Serplulimab combined with&#xD;
        Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage&#xD;
        II-III after surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</primary_completion_date>
    <phase>Phase 2</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>Disease-free survival</measure>
      <time_frame>3-year</time_frame>
      <description>DFS</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>3-year</time_frame>
      <description>OS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Side effects</measure>
      <time_frame>12 months]</time_frame>
      <description>Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">114</enrollment>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Adjuvant Chemotherapy only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Serplulimab</intervention_name>
      <description>Serplulimab: 4.5mg/Kg on day 1</description>
      <arm_group_label>Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trastuzuma</intervention_name>
      <description>Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1</description>
      <arm_group_label>Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chemotherapy</intervention_name>
      <description>Chemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease</description>
      <arm_group_label>Adjuvant Chemotherapy only</arm_group_label>
      <arm_group_label>Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Lower age limit of research subjects 20 years old and upper age limit of 80 years old.&#xD;
  &#xD;
            2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by&#xD;
               pathological evidences&#xD;
  &#xD;
            3. R0 gastrectomy with D2 lymphadenectomy&#xD;
  &#xD;
            4. Her2+ diagnosed by Immunohistochemistry or FISH&#xD;
  &#xD;
            5. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more&#xD;
               than 6 months&#xD;
  &#xD;
            6. No contraindications, including normal peripheral blood routine, liver and kidney&#xD;
               function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and&#xD;
               HGB≥80g/L).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with stage I and IV.&#xD;
  &#xD;
            2. Unavailable for R0 resection and D2 lymph node dissection.&#xD;
  &#xD;
            3. Multiple primary tumors&#xD;
  &#xD;
            4. Suffering from other serious diseases, including cardiovascular, respiratory, kidney,&#xD;
               or liver disease, complicated by poorly controlled hypertension, diabetes, mental&#xD;
               disorders or diseases.&#xD;
  &#xD;
            5. History of chemotherapy, radiotherapy, immunotherapy or target therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fudan University Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>2000000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dazhi Xu, MD,PHD</last_name>
        <phone>021-64175590</phone>
        <email>xudzh@shca.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Dazhi Xu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Gastric Cancer</keyword>
    <keyword>Adjuvant treatment</keyword>
    <keyword>Trastuzuma</keyword>
    <keyword>Serplulimab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_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/NCT05975749
  org study id: GC-her2
  nct id: NCT05975749
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to find out whether treatment with Serplulimab combined with
        Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage
        II-III after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Disease-free survival
  time frame: 3-year
  description: DFS
  measure: Overall survival
  time frame: 3-year
  description: OS
  measure: Side effects
  time frame: 12 months]
  description: Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder
  arm group label: Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy
  arm group type: Experimental
  arm group label: Adjuvant Chemotherapy only
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Serplulimab
  description: Serplulimab: 4.5mg/Kg on day 1
  arm group label: Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy
  intervention type: Drug
  intervention name: Trastuzuma
  description: Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1
  arm group label: Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy
  intervention type: Drug
  intervention name: Chemotherapy
  description: Chemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
  arm group label: Adjuvant Chemotherapy only
  arm group label: Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Dazhi Xu
  investigator title: Professor
  mesh term: Stomach Neoplasms
  sharing ipd: No