<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/NCT03802591</url>
  </required_header>
  <id_info>
    <org_study_id>CS1001-303</org_study_id>
    <nct_id>NCT03802591</nct_id>
  </id_info>
  <brief_title>A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma</brief_title>
  <official_title>A Multi-Center, Double-Blind, Randomized, Phase III Study of CS1001 in Combination With CAPOX Chemotherapy Compared to Placebo in Combination With CAPOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CStone Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CStone Pharmaceuticals</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the&#xD;
      efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX)&#xD;
      chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric&#xD;
      adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</measure>
    <time_frame>from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">479</enrollment>
  <condition>Gastric Adenocarcinoma</condition>
  <condition>Gastroesophageal Junction Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>CS1001 monoclonal antibody</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in combination with Oxaliplatin and Capecitabine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CS1001 placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>in combination with Oxaliplatin and Capecitabine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CS1001 monoclonal antibody</intervention_name>
    <description>Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months</description>
    <arm_group_label>CS1001 monoclonal antibody</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CS1001 placebo</intervention_name>
    <description>Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months</description>
    <arm_group_label>CS1001 placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Administered as an IV infusion on Day 1 Q3W</description>
    <arm_group_label>CS1001 monoclonal antibody</arm_group_label>
    <arm_group_label>CS1001 placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Administered by oral, twice a day on Day 1 - Day 14 of each cycle.</description>
    <arm_group_label>CS1001 monoclonal antibody</arm_group_label>
    <arm_group_label>CS1001 placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years but ≤ 75 years&#xD;
&#xD;
          2. Being able to follow the protocol requirements as per investigator's evaluation.&#xD;
&#xD;
          3. Provide written informed consent before any protocol-related procedure (that is not a&#xD;
             part of subject's routine care) is carried out.&#xD;
&#xD;
          4. Unresectable locally advanced or metastatic gastric carcinoma (GC) or&#xD;
             gastro-esophageal junction (GEJ) carcinoma, and have histologically confirmed&#xD;
             predominant adenocarcinoma.&#xD;
&#xD;
          5. The subject may have at least a measurable lesion or an evaluable lesion, if not&#xD;
             measurable; the investigator will carry out evaluation according to Response&#xD;
             Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to&#xD;
             randomization.&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.&#xD;
&#xD;
          7. Expected survival ≥ 3 months.&#xD;
&#xD;
          8. Subject must not have received systemic treatment (including HER2 inhibitor) for&#xD;
             advanced or metastatic gastric carcinoma.&#xD;
&#xD;
          9. Subject must provide tumor tissue samples for biomarker analysis in order to determine&#xD;
             the expression of PD-L1. According to central laboratory test, the PD-L1 expression is&#xD;
             ≥ 5% in tumor tissue (including PD-L1 expression in tumor cells and tumor infiltrating&#xD;
             immune cells).&#xD;
&#xD;
         10. Permitted prior treatment: Subjects with GC or GEJ carcinoma priorly treated with&#xD;
             adjuvant or neoadjuvant therapy, who experience clinical progression of disease at&#xD;
             least 6 months after last dose are allowed to be enrolled.&#xD;
&#xD;
         11. Subjects must have adequate organ function as assessed in the laboratory tests&#xD;
&#xD;
         12. Subjects with active hepatitis B or active hepatitis C must receive antiviral&#xD;
             treatment for at least 14 days prior to the first dose of study treatment and pass the&#xD;
             hepatitis B virus (HBV) DNA titer test (≤ 500 IU/mL or 2500 copies/mL) and hepatitis C&#xD;
             virus (HCV) RNA test (≤ lower limit of detection) before being enrolled. The subject&#xD;
             should be willing to continue effective anti-viral treatment during the study.&#xD;
&#xD;
         13. Female subject with childbearing potential must have negative serum pregnancy test&#xD;
             result at screening, except for those with available sterilization operation record or&#xD;
             post-menopausal subjects. Female subject with childbearing potential or male subjects&#xD;
             and their partners must agree to take effective contraceptive measures from the day of&#xD;
             signing ICF till at least 6 months after the last dosing of investigational product.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known HER-2 positivity.&#xD;
&#xD;
          2. A known additional primary malignancy that occurred within 5 years prior to the first&#xD;
             dose of investigational treatment, except for locally curable cancers that have been&#xD;
             apparently cured, such as basal or squamous cell skin cancer, superficial bladder&#xD;
             cancer, or carcinoma in situ of the prostate, cervix, or breast.&#xD;
&#xD;
          3. Known primary central nerve system (CNS) tumor or meningeal metastasis, or unstable&#xD;
             CNS metastasis (symptomatic within 4 weeks before first dose of investigational&#xD;
             product, requiring corticosteroid treatment, or without radiologic evidence supporting&#xD;
             stable status for over 4 weeks prior to the first dose of investigational product).&#xD;
&#xD;
          4. Any severe or uncontrolled systemic disease, for example diabetes mellitus or&#xD;
             hypertension, that may increase the risk associated with participation or&#xD;
             investigational product administration, or compromise subject's ability to receive&#xD;
             investigational product, as per investigator's judgment.&#xD;
&#xD;
          5. Known positive human immunodeficiency virus (HIV) or acquired immunodeficiency&#xD;
             syndrome (AIDS).&#xD;
&#xD;
          6. Has had prior chemotherapy, immune therapy, biological therapy (including cancer&#xD;
             vaccine, cytokine therapy or growth factors to control cancer) used as systemic&#xD;
             treatment for cancer, within 14 days before the first dose of investigational product.&#xD;
&#xD;
          7. Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins or&#xD;
             immune checkpoints pathways(including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-TIM3,&#xD;
             anti-LAG3 antibody, etc.).&#xD;
&#xD;
          8. Subjects with conditions that in the investigator's opinion are not suitable for&#xD;
             participating in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 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>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03802591
org study id: CS1001-303
nct id: NCT03802591
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the
      efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX)
      chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric
      adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
time frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months
measure: Overall survival (OS)
time frame: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months
arm group label: CS1001 monoclonal antibody
arm group type: Experimental
description: in combination with Oxaliplatin and Capecitabine
arm group label: CS1001 placebo
arm group type: Placebo Comparator
description: in combination with Oxaliplatin and Capecitabine
intervention type: Drug
intervention name: CS1001 monoclonal antibody
description: Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
arm group label: CS1001 monoclonal antibody
intervention type: Drug
intervention name: CS1001 placebo
description: Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
arm group label: CS1001 placebo
intervention type: Drug
intervention name: Oxaliplatin
description: Administered as an IV infusion on Day 1 Q3W
arm group label: CS1001 monoclonal antibody
arm group label: CS1001 placebo
intervention type: Drug
intervention name: Capecitabine
description: Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
arm group label: CS1001 monoclonal antibody
arm group label: CS1001 placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Antibodies
mesh term: Antibodies, Monoclonal