<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/NCT03278015</url>
  </required_header>
  <id_info>
    <org_study_id>XDB-001</org_study_id>
    <nct_id>NCT03278015</nct_id>
  </id_info>
  <brief_title>Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients</brief_title>
  <official_title>Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</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>
      Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method&#xD;
      clinically. Recently radical surgical resection is recommended for this cancer, How to&#xD;
      improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can&#xD;
      partly raise post-operative survival rate. the purpose of this study is to three chemotherapy&#xD;
      regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with&#xD;
      gemcitabine),which is best regimens for raising patients' survival rate, and will provide a&#xD;
      chemotherapy choice for clinic therapy of 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">October 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2018</primary_completion_date>
  <phase>Phase 2</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>Disease free survival(DFS)</measure>
    <time_frame>3 years</time_frame>
    <description>To determine the DFS of post-operative patients with pancreatic cancer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival time (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>To determine the OS post-operative patients with pancreatic cancer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>median overall survival time (mOS)</measure>
    <time_frame>5 years</time_frame>
    <description>To determine the mOS post-operative patients with pancreatic cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate(ORR)</measure>
    <time_frame>3 years</time_frame>
    <description>All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety profile</measure>
    <time_frame>3 years</time_frame>
    <description>Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate(DCR)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Cancer of Pancreas</condition>
  <arm_group>
    <arm_group_label>Nab-paclitaxel plus Gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S-1 monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel plus Gemcitabine</intervention_name>
    <description>Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.</description>
    <arm_group_label>Nab-paclitaxel plus Gemcitabine</arm_group_label>
    <other_name>nab-paclitaxel abraxane ABI-007</other_name>
    <other_name>GEMXAR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine monotherapy</intervention_name>
    <description>Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.</description>
    <arm_group_label>Gemcitabine monotherapy</arm_group_label>
    <other_name>GEMXAR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-1 monotherapy</intervention_name>
    <description>S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.</description>
    <arm_group_label>S-1 monotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed-consent form.&#xD;
&#xD;
          2. Man or woman aged 18 years to 80 years.&#xD;
&#xD;
          3. Histologically confirmed pancreatic carcinoma, and the histological type is ductal&#xD;
             adenocarcinoma.&#xD;
&#xD;
          4. Mild (Child-Pugh A), moderate (Child-Pugh B) and some preferable severe (Child-Pugh C,&#xD;
             &lt;=10) hepatic dysfunction according to the Child-Pugh Scoring system criteria.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life&#xD;
             expectation of no less than 12 weeks.&#xD;
&#xD;
          6. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x&#xD;
             109/L; platelets ≥ 70 x 109/L; hemoglobin ≥ 8.0 g/dL.&#xD;
&#xD;
          7. Albumin ≥ 30 g/L.&#xD;
&#xD;
          8. Adequate hepatic function as evidenced by Alanine aminotransferase (ALT) and Aspartate&#xD;
             aminotransferase (AST) ≤ 5 x upper limit of normal (ULN); Serum total bilirubin ≤ 1.5&#xD;
             x ULN; Serum creatinine ≤ 1.5 x ULN.&#xD;
&#xD;
          9. Females of childbearing potential must have a negative serum pregnancy test and must&#xD;
             not breast-feed before the first dose. Male also need contraception.&#xD;
&#xD;
         10. Willing and able to comply with study procedures for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypertension, and unable to drop to normal level (systolic pressure &gt;140 mmHg,&#xD;
             diastolic pressure &gt;90 mmHg) after treatment.&#xD;
&#xD;
          2. Patients have active cardiac disease including any of the following:&#xD;
&#xD;
               1. In resting state, average correction QTc &gt; 470 msec on mean value of 3 times&#xD;
                  screening ECGs.&#xD;
&#xD;
               2. Any clinically significant abnormal ECG form, for example, complete left bundle&#xD;
                  branch block, 3-degree atrioventricular block, 2-degree atrioventricular block,&#xD;
                  or PR interval &gt; 250 msec.&#xD;
&#xD;
               3. Any factors may increase the risk of QTc prolongation or arrhythmic event.&#xD;
&#xD;
               4. Left ventricular ejection fraction (LVEF) &lt; 50%.&#xD;
&#xD;
          3. Patient weight still in losing period.&#xD;
&#xD;
          4. History of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such as&#xD;
             esophageal varices with high risk of bleeding, local active ulcerative lesions, fecal&#xD;
             occult blood test&gt;= (+ +) within the past 6 months, shall not enter the trial. If&#xD;
             fecal occult blood test (+), the patient is requested for gastroscopy.&#xD;
&#xD;
          5. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess&#xD;
             within the past 28 days, should not enter the trial.&#xD;
&#xD;
          6. Patients with coagulant function abnormality (INR &gt; 1.5 or prothrombin time (PT) &gt; ULN&#xD;
             + 4 sec), with bleeding tendency or are treated with thrombolytic or anticoagulant&#xD;
             therapy.&#xD;
&#xD;
          7. Patients with unstable or serious concurrent medical conditions are excluded. The&#xD;
             researcher evaluates that the patient who is not suitable for participation in the&#xD;
             study. Patients with active infection, for example, HBV, HCV, or HIV.&#xD;
&#xD;
          8. Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to&#xD;
             swallow drugs, which may affect the fully absorption of S-1.&#xD;
&#xD;
          9. Patients with mental illness, or with psychiatric history of drug abuse.&#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_contact>
    <last_name>Dabin Xu, M.D.</last_name>
    <phone>8613522065659</phone>
    <email>xdabin@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Dabin Xu</investigator_full_name>
    <investigator_title>Associate Chief Doctor</investigator_title>
  </responsible_party>
  <keyword>S-1</keyword>
  <keyword>nab-paclitaxel</keyword>
  <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>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</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/NCT03278015
org study id: XDB-001
nct id: NCT03278015
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method
      clinically. Recently radical surgical resection is recommended for this cancer, How to
      improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can
      partly raise post-operative survival rate. the purpose of this study is to three chemotherapy
      regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with
      gemcitabine),which is best regimens for raising patients' survival rate, and will provide a
      chemotherapy choice for clinic therapy of pancreatic cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival(DFS)
time frame: 3 years
description: To determine the DFS of post-operative patients with pancreatic cancer
measure: overall survival time (OS)
time frame: 5 years
description: To determine the OS post-operative patients with pancreatic cancer
measure: median overall survival time (mOS)
time frame: 5 years
description: To determine the mOS post-operative patients with pancreatic cancer
measure: Objective Response Rate(ORR)
time frame: 3 years
description: All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations
measure: Quality of Life Assessment
time frame: 3 years
measure: safety profile
time frame: 3 years
description: Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups
measure: Disease control rate(DCR)
time frame: 3 years
arm group label: Nab-paclitaxel plus Gemcitabine
arm group type: Experimental
description: Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
arm group label: Gemcitabine monotherapy
arm group type: Experimental
description: Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
arm group label: S-1 monotherapy
arm group type: Experimental
description: S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
intervention type: Drug
intervention name: Nab-paclitaxel plus Gemcitabine
description: Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
arm group label: Nab-paclitaxel plus Gemcitabine
other name: nab-paclitaxel abraxane ABI-007
other name: GEMXAR
intervention type: Drug
intervention name: Gemcitabine monotherapy
description: Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
arm group label: Gemcitabine monotherapy
other name: GEMXAR
intervention type: Drug
intervention name: S-1 monotherapy
description: S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
arm group label: S-1 monotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dabin Xu, M.D.
phone: 8613522065659
email: xdabin@126.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Dabin Xu
investigator title: Associate Chief Doctor
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Gemcitabine