<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/NCT03801668</url>
  </required_header>
  <id_info>
    <org_study_id>TJCC008</org_study_id>
    <nct_id>NCT03801668</nct_id>
  </id_info>
  <brief_title>Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma</brief_title>
  <official_title>A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CSPC Ouyi Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Huazhong University of Science and Technology</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>
      It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus&#xD;
      Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric&#xD;
      adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>PFS is defined as time from the start of treatment to progression of disease or death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>The rate of participants that achieve either a complete response (CR) or a partial response (PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Overall survival is defined as time from the start of treatment until death due to any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety as measured by number and grade of adverse events</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Summary adverse events according to NCI-CTCAE 4.03</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">294</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Nab-P/S-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin-bound Paclitaxel plus S-1</intervention_name>
    <description>Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.</description>
    <arm_group_label>Nab-P/S-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin plus S-1</intervention_name>
    <description>Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.</description>
    <arm_group_label>SOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of 18-75 years;&#xD;
&#xD;
          2. Cytological or histological diagnosis of recurrent or metastatic gastric&#xD;
             adenocarcinoma;&#xD;
&#xD;
          3. At least one measurable lesion as defined by RECIST 1.1 criteria;&#xD;
&#xD;
          4. ECOG performance status of 0-1;&#xD;
&#xD;
          5. Estimated life expectancy of at least 3 months;&#xD;
&#xD;
          6. Left ventricular ejection fraction (LVEF) ≥ 50%;&#xD;
&#xD;
          7. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT)&#xD;
             ≥90×109 /L, hemoglobin(HB) ≥90 g/L;&#xD;
&#xD;
          8. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN);&#xD;
             alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper&#xD;
             limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with&#xD;
             hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN),&#xD;
             or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;&#xD;
&#xD;
          9. Not be breast-feeding; men and women of reproductive age are willing to take reliable&#xD;
             contraceptive measures during the study;&#xD;
&#xD;
         10. Able and willing to comply with the study plans in this protocol and sign the informed&#xD;
             consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have received chemotherapy before；patients that received neoadjuvant or adjuvant&#xD;
             chemotherapy are eligible provided the treatment is completed&gt;6 months prior to first&#xD;
             recurrence or metastasis;&#xD;
&#xD;
          2. HER-2 positive;&#xD;
&#xD;
          3. Patients with symptomatic brain metastases;&#xD;
&#xD;
          4. II-IV peripheral neuropathy [NCI-CTCAE 4.03];&#xD;
&#xD;
          5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with&#xD;
             active hepatitis ; anti-HIV antibody positive;&#xD;
&#xD;
          6. Patients with serious systemic infection or other diseases;&#xD;
&#xD;
          7. Allergic to the chemotherapy drugs or the materials in this study;&#xD;
&#xD;
          8. Patients with gastrointestinal bleeding that need clinical intervention;&#xD;
&#xD;
          9. Patients with digestive tract obstruction or oral nutrition difficulty;&#xD;
&#xD;
         10. Have a second malignancy within 5 years prior to registration except for cured&#xD;
             carcinoma in situ of cervix uteri, non-melanoma skin cancer;&#xD;
&#xD;
         11. Have participated in other clinical trials within 28 days prior to the first dose of&#xD;
             this study;&#xD;
&#xD;
         12. Contraindications to chemotherapy;&#xD;
&#xD;
         13. Patients that researcher consider cannot sign informed consent or complete the study&#xD;
             plan due to medical science factor, social factor or psychological reasons.&#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_official>
    <last_name>Xianglin Yuan, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xianglin Yuan, MD,PhD</last_name>
    <phone>8627-83663406</phone>
    <email>xlyuan1020@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hong Qiu, MD,PhD</last_name>
    <phone>8627-83663406</phone>
    <email>tjqiuhong@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xianglin Yuan, MD,PHD</last_name>
      <phone>8627-83663406</phone>
      <email>xlyuan1020@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Hong Qiu, MD,PHD</last_name>
      <phone>8627-83663406</phone>
      <email>tjqiuhong@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Xianglin Yuan, MD,PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hong Qiu, MD,PHD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Xianglin Yuan</investigator_full_name>
    <investigator_title>Professor, Head of the cancer center</investigator_title>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>Albumin-bound Paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03801668
org study id: TJCC008
nct id: NCT03801668
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus
      Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric
      adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free Survival (PFS)
time frame: up to 3 years
description: PFS is defined as time from the start of treatment to progression of disease or death.
measure: Overall Response Rate (ORR)
time frame: up to 3 years
description: The rate of participants that achieve either a complete response (CR) or a partial response (PR).
measure: Overall survival (OS)
time frame: up to 3 years
description: Overall survival is defined as time from the start of treatment until death due to any reason.
measure: Safety as measured by number and grade of adverse events
time frame: up to 3 years
description: Summary adverse events according to NCI-CTCAE 4.03
arm group label: Nab-P/S-1
arm group type: Experimental
description: Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.
arm group label: SOX
arm group type: Active Comparator
description: Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.
intervention type: Drug
intervention name: Albumin-bound Paclitaxel plus S-1
description: Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
arm group label: Nab-P/S-1
intervention type: Drug
intervention name: Oxaliplatin plus S-1
description: Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
arm group label: SOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xianglin Yuan, MD,PhD
role: Study Chair
affiliation: Tongji Hospital
last name: Xianglin Yuan, MD,PhD
phone: 8627-83663406
email: xlyuan1020@163.com
last name: Hong Qiu, MD,PhD
phone: 8627-83663406
email: tjqiuhong@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Xianglin Yuan
investigator title: Professor, Head of the cancer center
mesh term: Adenocarcinoma
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Oxaliplatin
mesh term: Albumin-Bound Paclitaxel
sharing ipd: Undecided