<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/NCT03768687</url>
  </required_header>
  <id_info>
    <org_study_id>EXPLORE-PC101</org_study_id>
    <nct_id>NCT03768687</nct_id>
  </id_info>
  <brief_title>A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer</brief_title>
  <official_title>A Real-world Study of on Albumin-bound Paclitaxel as First-line Treatment of Patients With Non-operative Locally Advanced or Metastatic Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</source>
  <oversight_info>
    <has_dmc>No</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>
      Pancreatic cancer progresses rapidly and has a higher death rate. Albumin-bound paclitaxel is&#xD;
      a new generation of paclitaxel . Albumin-bound paclitaxel is recommended as a class 1A&#xD;
      evidence treating patients with pancreatic cancer.The purpose of this study was to further&#xD;
      observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel in the&#xD;
      treatment of non-operative locally advanced or metastatic pancreatic cancer and to explore&#xD;
      the prognostic factors .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-arm, observational study. After the subjects meet the inclusive&#xD;
      and exclusive criteria, then they will receive albumin-bound paclitaxel treatment. The&#xD;
      researchers can choose the treatment based on albumin-bound paclitaxel and choose dosage&#xD;
      according to the patient's condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 20, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>3 weeks</time_frame>
    <description>the date from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first.</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pancreatic Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients enrolled in the study underwent whole-gene sequencing based on their willingness to&#xD;
      take tumor tissue samples and blood samples.All samples need tissue samples and peripheral&#xD;
      blood as control. Tissue samples can be wax blocks, fresh surgical tissues,tissues through&#xD;
      puncture biopsy, laparoscopic biopsy and other biopsy. Sampling should be conducted within 1&#xD;
      week before enrollment.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18 -80, male or female;&#xD;
&#xD;
          2. Non-operative patients with locally advanced or metastatic pancreatic cancer diagnosed&#xD;
             by pathology or histology (except islet cell carcinoma);&#xD;
&#xD;
          3. The patient has not received standard systematic treatment in the past, and the&#xD;
             metastatic site has not received any local treatment, including radiotherapy,&#xD;
             chemotherapy, surgical treatment, etc.;&#xD;
&#xD;
          4. At least one measurable lesion (CT scan length of tumor lesion is greater than 10 mm,&#xD;
             CT scan short diameter of lymph node lesion is greater than 15 mm, scanning layer&#xD;
             thickness is not greater than 5 mm);&#xD;
&#xD;
          5. The subjects volunteered to participate in this study and signed the informed consent&#xD;
             form, with good compliance to follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women;&#xD;
&#xD;
          2. Patients allergy to albumin-bound paclitaxel or its excipients&#xD;
&#xD;
          3. Patients with albumin-bound paclitaxel contraindication;&#xD;
&#xD;
          4. Doctors consider those who are not suitable for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baorui Liu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Affiliated Hospital of Nanjing University Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Baorui Liu, Doctor</last_name>
    <phone>13770621908</phone>
    <email>baoruiliu07@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juan Du, Doctor</last_name>
    <phone>13951826526</phone>
    <email>dujunglyy@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Affiliated Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Baorui Liu, Doctor</last_name>
      <phone>13770621908</phone>
      <email>baoruiliu07@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Juan Du, Doctor</last_name>
      <phone>13951826526</phone>
      <email>dujunglyy@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
    <investigator_full_name>Baorui Liu</investigator_full_name>
    <investigator_title>chief doctor</investigator_title>
  </responsible_party>
  <keyword>pancreatic cancer</keyword>
  <keyword>albumin-bound paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_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/NCT03768687
org study id: EXPLORE-PC101
nct id: NCT03768687
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pancreatic cancer progresses rapidly and has a higher death rate. Albumin-bound paclitaxel is
      a new generation of paclitaxel . Albumin-bound paclitaxel is recommended as a class 1A
      evidence treating patients with pancreatic cancer.The purpose of this study was to further
      observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel in the
      treatment of non-operative locally advanced or metastatic pancreatic cancer and to explore
      the prognostic factors .
This is a prospective, single-arm, observational study. After the subjects meet the inclusive
      and exclusive criteria, then they will receive albumin-bound paclitaxel treatment. The
      researchers can choose the treatment based on albumin-bound paclitaxel and choose dosage
      according to the patient's condition.
observational model: Cohort
time perspective: Prospective
measure: Progression free survival
time frame: 3 weeks
description: the date from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Patients enrolled in the study underwent whole-gene sequencing based on their willingness to
      take tumor tissue samples and blood samples.All samples need tissue samples and peripheral
      blood as control. Tissue samples can be wax blocks, fresh surgical tissues,tissues through
      puncture biopsy, laparoscopic biopsy and other biopsy. Sampling should be conducted within 1
      week before enrollment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Baorui Liu, Doctor
role: Principal Investigator
affiliation: The Affiliated Hospital of Nanjing University Medical School
last name: Baorui Liu, Doctor
phone: 13770621908
email: baoruiliu07@163.com
last name: Juan Du, Doctor
phone: 13951826526
email: dujunglyy@163.com
facility: 
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
investigator full name: Baorui Liu
investigator title: chief doctor
mesh term: Pancreatic Neoplasms
sharing ipd: Undecided