<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/NCT03779464</url>
  </required_header>
  <id_info>
    <org_study_id>XHZL-001</org_study_id>
    <nct_id>NCT03779464</nct_id>
  </id_info>
  <brief_title>Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas</brief_title>
  <official_title>Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Union Hospital, China</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>
      A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine&#xD;
      verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic&#xD;
      pancreatic cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination&#xD;
      with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor&#xD;
      response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced&#xD;
      or metastatic adenocarcinoma of the pancreas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>6 month</time_frame>
    <description>progression-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>1 year</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>6 month</time_frame>
    <description>objective response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>6 month</time_frame>
    <description>CR+PR+SD was defined as disease control rate (DCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profile :Adverse events of nab-Paclitaxel plus S-1</measure>
    <time_frame>1 year</time_frame>
    <description>Adverse events of nab-Paclitaxel plus S-1</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Nab-paclitaxel</condition>
  <condition>Gemcitabine</condition>
  <condition>S1</condition>
  <arm_group>
    <arm_group_label>S/nab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area &lt; 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area &gt;1.5 m²; D1-14, q3w)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gem/nab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S1 or Gemcitabine</intervention_name>
    <description>Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area &lt; 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area &gt;1.5 m²; D1-14, q3w)</description>
    <arm_group_label>Gem/nab</arm_group_label>
    <arm_group_label>S/nab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological confirmation of pancreatic adenocarcinoma&#xD;
&#xD;
          -  Distant metastatic or unresctable locally advanced diseases&#xD;
&#xD;
          -  CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of&#xD;
             treatment&#xD;
&#xD;
          -  At least one lesion measurable by RECIST v1.1 criteria&#xD;
&#xD;
          -  Life expectancy&gt; 3 months&#xD;
&#xD;
          -  No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if&#xD;
             administered more than 6 months prior to inclusion)&#xD;
&#xD;
          -  No previous radiotherapy (unless at least one measurable target lesion outside the&#xD;
             irradiation zone)&#xD;
&#xD;
          -  Pain must be monitored before inclusion&#xD;
&#xD;
          -  18 years &lt; age &lt; 70&#xD;
&#xD;
          -  Performance status: 0-1&#xD;
&#xD;
          -  ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL&#xD;
&#xD;
          -  ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found&#xD;
&#xD;
          -  Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),&#xD;
&#xD;
          -  creatinine &lt; 120 μmol/L, or MDRD creatinine clearance &gt; 60 mL/min&#xD;
&#xD;
          -  Patient information and signature of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent other effective treatment (including radiotherapy)&#xD;
&#xD;
          -  Resectable patients&#xD;
&#xD;
          -  Allergy history to other drugs in the same class patients with pregnancy or lactation&#xD;
&#xD;
          -  Known severe internal medical diseases&#xD;
&#xD;
          -  Abnormal heart function or relevant history of myocardial infarction and severe&#xD;
             arrhythmia&#xD;
&#xD;
          -  Immunocompromised patients, such as HIV positive&#xD;
&#xD;
          -  Uncontrollable mental illness&#xD;
&#xD;
          -  Other conditions the researchers considered ineligible for 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_contact>
    <last_name>Zhenyu lin, MD</last_name>
    <phone>86-27-85871982</phone>
    <email>whxhlzy@hust.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tao Zhang, MD</last_name>
    <phone>86-27-85871982</phone>
    <email>taozhangxh@hust.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu Hu, MD</last_name>
      <phone>027-85726114</phone>
      <email>284409937@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.</citation>
    <PMID>24131140</PMID>
  </results_reference>
  <results_reference>
    <citation>Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.</citation>
    <PMID>23547081</PMID>
  </results_reference>
  <results_reference>
    <citation>Xu Y, Guo X, Fan Y, Wang D, Wu W, Wu L, Liu T, Xu B, Feng Y, Wang Y, Lou W, Zhou Y. Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Jpn J Clin Oncol. 2018 Jun 1;48(6):535-541. doi: 10.1093/jjco/hyy063.</citation>
    <PMID>29718363</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</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>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Tao Zhang</investigator_full_name>
    <investigator_title>Chief of Gastrointestinal Oncology</investigator_title>
  </responsible_party>
  <keyword>pancreatic cancer</keyword>
  <keyword>nab-paclitaxel</keyword>
  <keyword>gemcitabine</keyword>
  <keyword>S1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</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/NCT03779464
org study id: XHZL-001
nct id: NCT03779464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine
      verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic
      pancreatic cancer
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination
      with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor
      response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced
      or metastatic adenocarcinoma of the pancreas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: PFS
time frame: 6 month
description: progression-free survival
measure: OS
time frame: 1 year
description: overall survival
measure: ORR
time frame: 6 month
description: objective response rate
measure: DCR
time frame: 6 month
description: CR+PR+SD was defined as disease control rate (DCR)
measure: Safety profile :Adverse events of nab-Paclitaxel plus S-1
time frame: 1 year
description: Adverse events of nab-Paclitaxel plus S-1
arm group label: S/nab
arm group type: Experimental
description: Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
arm group label: Gem/nab
arm group type: Active Comparator
description: Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)
intervention type: Drug
intervention name: S1 or Gemcitabine
description: Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
arm group label: Gem/nab
arm group label: S/nab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhenyu lin, MD
phone: 86-27-85871982
email: whxhlzy@hust.edu.cn
last name: Tao Zhang, MD
phone: 86-27-85871982
email: taozhangxh@hust.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
PMID: 24131140
citation: Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
PMID: 23547081
citation: Xu Y, Guo X, Fan Y, Wang D, Wu W, Wu L, Liu T, Xu B, Feng Y, Wang Y, Lou W, Zhou Y. Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Jpn J Clin Oncol. 2018 Jun 1;48(6):535-541. doi: 10.1093/jjco/hyy063.
PMID: 29718363
responsible party type: Principal Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Tao Zhang
investigator title: Chief of Gastrointestinal Oncology
mesh term: Adenocarcinoma
mesh term: Pancreatic Neoplasms
mesh term: Gemcitabine
sharing ipd: Undecided