<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/NCT03825328</url>
  </required_header>
  <id_info>
    <org_study_id>HZ-NS/GEMOX-PC</org_study_id>
    <nct_id>NCT03825328</nct_id>
  </id_info>
  <brief_title>A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )</brief_title>
  <official_title>A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yanqiao Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harbin Medical 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>
      This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS&#xD;
      Chemotherapy in Patients With untreated Pancreatic cancer.&#xD;
&#xD;
      This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a&#xD;
      first-line treatment of untreated Pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 30, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2020</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>PFS</measure>
    <time_frame>from the first drug administration up to 6 months</time_frame>
    <description>progression-free survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OS</measure>
    <time_frame>from the first drug administration up to 1 year</time_frame>
    <description>overall survival</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin-bound paclitaxel</intervention_name>
    <description>Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-1</intervention_name>
    <description>a combination preparation of tegafur, gimeracil, and oteracil potassium</description>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>The compound features a square planar platinum(II) center. In contrast to cisplatin and carboplatin, oxaliplatin features the bidentate ligand 1,2-diaminocyclohexane in place of the two monodentate ammine ligands. It also features a bidentate oxalate group.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Gemcitabine is a synthetic pyrimidine nucleoside prodrug-a nucleoside analog in which the hydrogen atoms on the 2' carbon of deoxycytidine are replaced by fluorine atoms.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily participate in the trial and sign the informed consent form&#xD;
&#xD;
          2. 18 years old &lt;age &lt;75 years old&#xD;
&#xD;
          3. Histopathological or cytologically confirmed (inoperable) locally advanced or&#xD;
             recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable&#xD;
             according to RECIST criteria&#xD;
&#xD;
          4. ECOG score 0-1&#xD;
&#xD;
          5. Life expectancy &gt; 3 months&#xD;
&#xD;
          6. There must be a CT or MRI examination within a week&#xD;
&#xD;
          7. at least one lesion that can be measured by the RECIST v1.1 standard&#xD;
&#xD;
          8. No chemotherapy has been performed (the interval between postoperative adjuvant&#xD;
             chemotherapy must be more than 6 months)&#xD;
&#xD;
          9. without radiation therapy (unless there is at least one measurable target lesion in&#xD;
             the non-irradiated area)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnant or lactating women; or those who have fertility but refuse to take&#xD;
             contraceptive measures;&#xD;
&#xD;
          2. Severe active infections requiring intravenous antibiotic treatment during enrollment;&#xD;
&#xD;
          3. those who are allergic to the test drug;&#xD;
&#xD;
          4. There is ≥2 neuropathy (CTCAE 4.0);&#xD;
&#xD;
          5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable&#xD;
             psychiatric disorders; severe intellectual or cognitive dysfunction;&#xD;
&#xD;
          6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6&#xD;
             months, unstable angina, stroke or transient ischemic attack;&#xD;
&#xD;
          7. Have other malignant tumors within 5 years, except for fully treated cervical&#xD;
             carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of&#xD;
             the skin that has been basically controlled;&#xD;
&#xD;
          8. Patients who are unable to follow the protocol or who are unable to follow up;&#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_contact>
    <last_name>Zhang Yanqiao, PHD</last_name>
    <phone>13845120210</phone>
    <email>yanqiaozhang@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wang Guangyu, PHD</last_name>
    <phone>18249038966</phone>
    <email>18249038966@163.com</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Yanqiao Zhang</investigator_full_name>
    <investigator_title>Director of the hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic 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>Gemcitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</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/NCT03825328
org study id: HZ-NS/GEMOX-PC
nct id: NCT03825328
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS
      Chemotherapy in Patients With untreated Pancreatic cancer.

      This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a
      first-line treatment of untreated Pancreatic cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: from the first drug administration up to 6 months
description: progression-free survival
measure: OS
time frame: from the first drug administration up to 1 year
description: overall survival
arm group label: Chemotherapy
arm group type: Experimental
description: Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
intervention type: Drug
intervention name: Albumin-bound paclitaxel
description: Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.
arm group label: Chemotherapy
intervention type: Drug
intervention name: S-1
description: a combination preparation of tegafur, gimeracil, and oteracil potassium
arm group label: Chemotherapy
intervention type: Drug
intervention name: Oxaliplatin
description: The compound features a square planar platinum(II) center. In contrast to cisplatin and carboplatin, oxaliplatin features the bidentate ligand 1,2-diaminocyclohexane in place of the two monodentate ammine ligands. It also features a bidentate oxalate group.
arm group label: Chemotherapy
intervention type: Drug
intervention name: Gemcitabine
description: Gemcitabine is a synthetic pyrimidine nucleoside prodrug-a nucleoside analog in which the hydrogen atoms on the 2' carbon of deoxycytidine are replaced by fluorine atoms.
arm group label: Chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhang Yanqiao, PHD
phone: 13845120210
email: yanqiaozhang@126.com
last name: Wang Guangyu, PHD
phone: 18249038966
email: 18249038966@163.com
responsible party type: Sponsor-Investigator
investigator affiliation: Harbin Medical University
investigator full name: Yanqiao Zhang
investigator title: Director of the hospital
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Oxaliplatin
mesh term: Albumin-Bound Paclitaxel