<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/NCT02981719</url>
  </required_header>
  <id_info>
    <org_study_id>Y2016-MS-001</org_study_id>
    <nct_id>NCT02981719</nct_id>
  </id_info>
  <brief_title>Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer</brief_title>
  <official_title>Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuda Cancer Hospital, Guangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fuda Cancer Hospital, Guangzhou</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study was to compare the therapeutic efficacy between simultaneous&#xD;
      gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer&#xD;
      (LAPC)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2&#xD;
      gemcitabine hydrochloride [Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China]&#xD;
      intravenously (over approximately 30 min).&#xD;
&#xD;
      In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion&#xD;
      before IRE.&#xD;
&#xD;
      The aim of this study was to evslusted the overall survival (OS), objective response rate&#xD;
      (ORR) and adverse events after simultaneous therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety (number of adverse effects)</measure>
    <time_frame>3 month</time_frame>
    <description>Adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor response</measure>
    <time_frame>12 months</time_frame>
    <description>Imaging evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>36 months</time_frame>
    <description>Overall survival (OS) was defined using time of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrate antigen 19-9 (CA19-9)</measure>
    <time_frame>1 month</time_frame>
    <description>carbohydrate antigen 19-9 (CA19-9) levels were measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success of ablation</measure>
    <time_frame>3 months</time_frame>
    <description>The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>simultaneous gemcitabine and irreversible electroporation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gemcitabine intravenous infusion prior to irreversible electroporation treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IRE group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>percutaneous irreversible electroporation for locally advanced pancreatic cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>simultaneous gemcitabine and irreversible electroporation</intervention_name>
    <description>gemcitabine intravenous infusion prior to irreversible electroporation treatment</description>
    <arm_group_label>simultaneous gemcitabine and irreversible electroporation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>irreversible electroporation</intervention_name>
    <description>percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.</description>
    <arm_group_label>IRE group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least&#xD;
             CT of chest and abdomen&#xD;
&#xD;
          -  Screening must be performed no longer than 2 weeks prior to study inclusion&#xD;
&#xD;
          -  Maximum tumor diameter ≤ 5 cm&#xD;
&#xD;
          -  Histological or cytological confirmation of pancreatic adenocarcinoma;&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  PS-classification 0 - 2&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks&#xD;
&#xD;
          -  Adequate bone marrow, liver and renal function as assessed by the following laboratory&#xD;
             requirements to be conducted within 7 days prior to definite inclusion;&#xD;
&#xD;
          -  Hemoglobin level ≥ 115 g/L&#xD;
&#xD;
          -  Platelet count ≥ 100*109/l&#xD;
&#xD;
          -  Neutrophil count ≥ 2×109/L;&#xD;
&#xD;
          -  White blood cell count ≥ 4 ×109/L;&#xD;
&#xD;
          -  ALT and AST ≤ 2.5 x ULN&#xD;
&#xD;
          -  Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min&#xD;
&#xD;
          -  Prothrombin time or INR &lt; 1.5 x ULN&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary&#xD;
             hepatobiliary team&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  History of cardiac disease:&#xD;
&#xD;
          -  Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for&#xD;
             antihypertensive regimen are permitted)&#xD;
&#xD;
          -  Compromised liver function (e.g. signs of portal hypertension, INR &gt; 1,5 without use&#xD;
             of anticoagulants, ascites)&#xD;
&#xD;
          -  Uncontrolled infections (&gt; grade 2 NCI-CTC version 3.0)&#xD;
&#xD;
          -  Pregnant. Women of childbearing potential must have a negative pregnancy test&#xD;
             performed within 7 days of the start of treatment&#xD;
&#xD;
          -  Allergy to contrast media&#xD;
&#xD;
          -  Any implanted stimulation device&#xD;
&#xD;
          -  Any implanted metal stent/device within the area of ablation that cannot be removed&#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>Lizhi Niu, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Fuda Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FUDA Cancer Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 31, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>January 17, 2021</last_update_submitted>
  <last_update_submitted_qc>January 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>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/NCT02981719
org study id: Y2016-MS-001
nct id: NCT02981719
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to compare the therapeutic efficacy between simultaneous
      gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer
      (LAPC)
in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2
      gemcitabine hydrochloride [Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China]
      intravenously (over approximately 30 min).

      In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion
      before IRE.

      The aim of this study was to evslusted the overall survival (OS), objective response rate
      (ORR) and adverse events after simultaneous therapy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Safety (number of adverse effects)
time frame: 3 month
description: Adverse events
measure: Tumor response
time frame: 12 months
description: Imaging evaluation
measure: Overall survival (OS)
time frame: 36 months
description: Overall survival (OS) was defined using time of death.
measure: Carbohydrate antigen 19-9 (CA19-9)
time frame: 1 month
description: carbohydrate antigen 19-9 (CA19-9) levels were measured.
measure: Technical success of ablation
time frame: 3 months
description: The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone.
arm group label: simultaneous gemcitabine and irreversible electroporation
arm group type: Experimental
description: gemcitabine intravenous infusion prior to irreversible electroporation treatment.
arm group label: IRE group
arm group type: Other
description: percutaneous irreversible electroporation for locally advanced pancreatic cancer.
intervention type: Procedure
intervention name: simultaneous gemcitabine and irreversible electroporation
description: gemcitabine intravenous infusion prior to irreversible electroporation treatment
arm group label: simultaneous gemcitabine and irreversible electroporation
intervention type: Procedure
intervention name: irreversible electroporation
description: percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
arm group label: IRE group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lizhi Niu, PHD
role: Study Chair
affiliation: Fuda Cancer Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Gemcitabine
sharing ipd: Undecided