<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/NCT03263741</url>
  </required_header>
  <id_info>
    <org_study_id>AHQU-2017002</org_study_id>
    <nct_id>NCT03263741</nct_id>
  </id_info>
  <brief_title>Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer</brief_title>
  <official_title>Exploratory Study on the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin Chemotherapy in the Patients With Locally Advanced or Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital of Qinghai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Hospital of Qinghai University</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>
      Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in&#xD;
      the Patients with Locally Advanced or Advanced Gastric Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients&#xD;
      with Locally Advanced or Advanced Gastric Cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</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>Objective response rate(ORR)</measure>
    <time_frame>2 years</time_frame>
    <description>The sum of complete remission (CR) rate and partial remission (PR) rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival(PFS)</measure>
    <time_frame>2 years</time_frame>
    <description>From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival(OS)</measure>
    <time_frame>2 years</time_frame>
    <description>From date of enrollment until the date of death from any cause, assessed up to 60 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate(DCR)</measure>
    <time_frame>2 years</time_frame>
    <description>The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Paclitaxel + S-1 + Oxaliplatin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) &lt; 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to &lt; 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel + S-1 + Oxaliplatin</intervention_name>
    <description>Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) &lt; 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to &lt; 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week.&#xD;
Oxaliplatin: 85 mg/m2, iv, 2h, at D1.</description>
    <arm_group_label>Paclitaxel + S-1 + Oxaliplatin group</arm_group_label>
    <other_name>Paclitaxel + S-1 + Oxaliplatin chemotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histopathology or cytopathology proven gastric cancer or gastroesophageal&#xD;
             adenocarcinoma;&#xD;
&#xD;
          2. Locally advanced, or recurrent, or metastasis disease；&#xD;
&#xD;
          3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy&#xD;
             completed;&#xD;
&#xD;
          4. Life expectancy of at least 3 months;&#xD;
&#xD;
          5. ECOG score 0-1;&#xD;
&#xD;
          6. Age: 18~70 years old;&#xD;
&#xD;
          7. Normal hemodynamic indices before the recruitment (including blood cell count and&#xD;
             liver/kidney function). For example: WBC&gt;4.0×109/L, NEU &gt;1.5×109/L, PLT&gt;100×109/L,&#xD;
             BIL&lt;1.5 times of upper limit of normal reference value, ALT and AST&lt;2.5 times of upper&#xD;
             limit of normal reference value, and CRE&lt;1.2mg/dl;&#xD;
&#xD;
          8. Good cardiac function before the recruitment, no seizure of myocardial infarction in&#xD;
             past half year, and controllable hypertension and other coronary heart diseases;&#xD;
&#xD;
          9. Not concomitant with other uncontrollable benign diseases before the recruitment (e.g.&#xD;
             the infection in the lung, kidney and liver);&#xD;
&#xD;
         10. Not participating in other study projects before and during the treatment;&#xD;
&#xD;
         11. Voluntarily signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previously treated with first-line chemotherapy;&#xD;
&#xD;
          2. Allergy to the drugs in this protocol;&#xD;
&#xD;
          3. Pregnant or lactating women;&#xD;
&#xD;
          4. Women at childbearing age and of pregnancy desire during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiuda Zhao, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Qinghai University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiuda Zhao, M.D.</last_name>
    <phone>+8613327661976</phone>
    <email>jiudazhao@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Affiliated Hospital of Qinghai University</name>
      <address>
        <city>Xining</city>
        <state>Qinghai</state>
        <zip>810000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiuda Zhao, M.D.</last_name>
      <phone>+8613327661976</phone>
      <email>jiudazhao@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Dengfeng Ren, M.D.</last_name>
      <phone>+8613086297659</phone>
      <email>dengfeng1104@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Affiliated Hospital of Qinghai University</investigator_affiliation>
    <investigator_full_name>Jiuda Zhao</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Paclitaxel</keyword>
  <keyword>S-1</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>Efficiency</keyword>
  <keyword>safety</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>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Oxaliplatin</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/NCT03263741
org study id: AHQU-2017002
nct id: NCT03263741
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in
      the Patients with Locally Advanced or Advanced Gastric Cancer
To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients
      with Locally Advanced or Advanced Gastric Cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate(ORR)
time frame: 2 years
description: The sum of complete remission (CR) rate and partial remission (PR) rate.
measure: Progression-free survival(PFS)
time frame: 2 years
description: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
measure: Overall survival(OS)
time frame: 2 years
description: From date of enrollment until the date of death from any cause, assessed up to 60 months
measure: Disease control rate(DCR)
time frame: 2 years
description: The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year
arm group label: Paclitaxel + S-1 + Oxaliplatin group
arm group type: Experimental
description: Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
intervention type: Drug
intervention name: Paclitaxel + S-1 + Oxaliplatin
description: Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week.
Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
arm group label: Paclitaxel + S-1 + Oxaliplatin group
other name: Paclitaxel + S-1 + Oxaliplatin chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jiuda Zhao, M.D.
role: Principal Investigator
affiliation: Affiliated Hospital of Qinghai University
last name: Jiuda Zhao, M.D.
phone: +8613327661976
email: jiudazhao@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Affiliated Hospital of Qinghai University
investigator full name: Jiuda Zhao
investigator title: Professor
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Oxaliplatin