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/NCT06034964</url>
    </required_header>
    <id_info>
      <org_study_id>NCC3221</org_study_id>
      <nct_id>NCT06034964</nct_id>
    </id_info>
    <brief_title>Tislelizumab Combined With Chemotherapy in First-line Treatment of AGC</brief_title>
    <official_title>Retrospective Study of Tislelizumab Combined With Chemotherapy in First-line Treatment of HER2-negative Advanced Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-center, retrospective clinical study to evaluate the efficacy and safety of&#xD;
        tislelizumab combined with first-line chemotherapy in the treatment of HER2-negative advanced&#xD;
        gastric cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to include 60 HER-2 negative advanced gastric cancer patients who received&#xD;
        first-line treatment with tislelizumab combined with chemotherapy in our hospital from&#xD;
        November 1, 2020 to November 1, 2021. Clinicopathological data, blood tests and imaging data&#xD;
        of the patients were collected. The primary endpoints evaluated were PFS and OS, and the&#xD;
        secondary endpoints were ORR and safety. At the same time, ctDNA and peripheral cytokine&#xD;
        status of patients as well as second-generation sequencing of tumor tissues at baseline were&#xD;
        collected for the exploration of therapeutic efficacy related biomarkers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 1, 2020</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Actual">November 1, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>PFS</measure>
      <time_frame>2 years</time_frame>
      <description>Progression-free Survival</description>
    </primary_outcome>
    <primary_outcome>
      <measure>OS</measure>
      <time_frame>3 years</time_frame>
      <description>Overall Survival</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ORR</measure>
      <time_frame>2 years</time_frame>
      <description>Objective Remission Rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DCR</measure>
      <time_frame>2 years</time_frame>
      <description>Disease Control Rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DOR</measure>
      <time_frame>2 years</time_frame>
      <description>Duration of Remission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety and Tolerability</measure>
      <time_frame>2 years</time_frame>
      <description>Incidence of Treatment-Emergent Adverse Events</description>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Tislelizumab</condition>
    <condition>Chemotherapy</condition>
    <condition>First-line</condition>
    <condition>Gastric Cancer Stage IV</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tislelizumab</intervention_name>
      <description>Tislelizumab：200mg, iv, d1, 21 days per cycle, until disease progression or intolerable toxicity</description>
      <other_name>BGB-A317</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood sample&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          HER-2 negative, untreated patients with advanced gastric cancer.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with initially unresectable (locally advanced or metastatic) or postoperative&#xD;
               recurrence of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma&#xD;
               confirmed by histopathology have not received any anti-tumor treatment for advanced&#xD;
               gastric cancer in the past;&#xD;
  &#xD;
            2. Pathological immunohistochemistry or FISH detection of gastric cancer tissue indicates&#xD;
               negative Her-2;&#xD;
  &#xD;
            3. Age range from 18 to 70 years old, regardless of gender;&#xD;
  &#xD;
            4. The distance between postoperative recurrence and the end of neoadjuvant/adjuvant&#xD;
               chemotherapy is more than 6 months;&#xD;
  &#xD;
            5. If the patient experiences toxic side effects after receiving new adjuvant/adjuvant&#xD;
               treatment, they need to recover from previous treatment toxic side effects to ≤ 1&#xD;
               level; According to the RECIST evaluation criteria, there should be at least one&#xD;
               assessable lesion. Expected survival time ≥ 3 months;&#xD;
  &#xD;
          7. ECOG score ≤ 2 points; 8. Main organ functions are basically normal, blood count (within&#xD;
          7 days): hemoglobin ≥ 90g/L, white blood cells ≥ 4.0 × 109/L, neutrophils ≥ 2.0 × 109/L,&#xD;
          platelet ≥ 100.0 × 109/L. Total bilirubin 1.0 UNL, creatinine 1.0 × UNL, AST/ALT 2.5 UNL.&#xD;
          Liver metastasis: ASAT/ALAT 5 UNL; 9. The electrocardiogram/cardiac function tests are&#xD;
          basically normal.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Suffering from undifferentiated gastric cancer or squamous cell carcinoma of the&#xD;
               gastroesophageal junction and other pathological types of malignant tumors;&#xD;
  &#xD;
            2. Have received anti-tumor treatment for gastric adenocarcinoma or adenocarcinoma at the&#xD;
               junction of stomach and esophagus that can not be operated on for the first time or&#xD;
               recur after operation, including but not limited to chemotherapy, Targeted therapy,&#xD;
               immunotherapy, etc. (except for Thymosin and traditional Chinese medicine treatment);&#xD;
  &#xD;
            3. Patients with other primary malignant tumors other than gastric cancer, excluding&#xD;
               cured skin Basal-cell carcinoma and cervical Carcinoma in situ;&#xD;
  &#xD;
            4. Patients with simple or combined brain metastasis;&#xD;
  &#xD;
            5. Has experienced gastrointestinal perforation or fistula within 6 months prior to&#xD;
               enrollment;&#xD;
  &#xD;
            6. Patients who also suffer from other important organ diseases, including severe heart&#xD;
               disease;&#xD;
  &#xD;
            7. Complications such as uncontrollable moderate to massive ascites, active&#xD;
               gastrointestinal bleeding, gastrointestinal perforation, gastrointestinal obstruction,&#xD;
               etc;&#xD;
  &#xD;
            8. Patients with chronic diseases such as hypertension, hyperglycemia, and COPD that are&#xD;
               difficult to control;&#xD;
  &#xD;
            9. Those who require antibiotics for systemic anti infection, active hepatitis, active&#xD;
               pulmonary tuberculosis, and other diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lin Yang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Tislelizumab</keyword>
    <keyword>First-line</keyword>
    <keyword>Gastric cancer</keyword>
    <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>Tislelizumab</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/NCT06034964
  org study id: NCC3221
  nct id: NCT06034964
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a single-center, retrospective clinical study to evaluate the efficacy and safety of
        tislelizumab combined with first-line chemotherapy in the treatment of HER2-negative advanced
        gastric cancer.
  This study aims to include 60 HER-2 negative advanced gastric cancer patients who received
        first-line treatment with tislelizumab combined with chemotherapy in our hospital from
        November 1, 2020 to November 1, 2021. Clinicopathological data, blood tests and imaging data
        of the patients were collected. The primary endpoints evaluated were PFS and OS, and the
        secondary endpoints were ORR and safety. At the same time, ctDNA and peripheral cytokine
        status of patients as well as second-generation sequencing of tumor tissues at baseline were
        collected for the exploration of therapeutic efficacy related biomarkers.
  observational model: Cohort
  time perspective: Retrospective
  measure: PFS
  time frame: 2 years
  description: Progression-free Survival
  measure: OS
  time frame: 3 years
  description: Overall Survival
  measure: ORR
  time frame: 2 years
  description: Objective Remission Rate
  measure: DCR
  time frame: 2 years
  description: Disease Control Rate
  measure: DOR
  time frame: 2 years
  description: Duration of Remission
  measure: Safety and Tolerability
  time frame: 2 years
  description: Incidence of Treatment-Emergent Adverse Events
  intervention type: Drug
  intervention name: Tislelizumab
  description: Tislelizumab：200mg, iv, d1, 21 days per cycle, until disease progression or intolerable toxicity
  other name: BGB-A317
  Blood sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lin Yang
  role: Principal Investigator
  affiliation: Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms
  mesh term: Tislelizumab