<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/NCT02973217</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-2015-008</org_study_id>
    <nct_id>NCT02973217</nct_id>
  </id_info>
  <brief_title>Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer</brief_title>
  <official_title>Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Laserthermia Systems AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Laserthermia Systems AB</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.&#xD;
      Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of&#xD;
      thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a&#xD;
      tumor specific immunologic response. In laboratory animals the imILT method has also been&#xD;
      shown to induce a so called abscopal effect. This means that when one tumor is treated with&#xD;
      imILT other, untreated, tumors also decrease in size.&#xD;
&#xD;
      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction&#xD;
      of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is&#xD;
      also to investigate the functionality and safety as well as understanding of the subsequent&#xD;
      immunological effects.&#xD;
&#xD;
      This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic&#xD;
      cancer will be treated in this trial, which is estimated to be carried out during a time&#xD;
      period of 36 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">April 29, 2019</primary_completion_date>
  <phase>N/A</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>Safety (adverse events)</measure>
    <time_frame>36 months</time_frame>
    <description>Evaluation of adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory response in circulation measured by quantification of inflammatory cell populations</measure>
    <time_frame>36 months</time_frame>
    <description>Quantification of cellular infiltrate and activation markers by flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease progression</measure>
    <time_frame>36 months</time_frame>
    <description>Analysis of the percentage of patients with no new oncological events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Quality of Life (using questionnaires)</measure>
    <time_frame>36 months</time_frame>
    <description>Evaluation of Quality of Life is evaluated using standardized questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability of the device as evaluated by treatment logs</measure>
    <time_frame>36 months</time_frame>
    <description>Evaluation of the laser system by analysis of treatment logs of the device.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Neoplasms Pancreatic</condition>
  <arm_group>
    <arm_group_label>imILT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immunostimulating Interstitial Laser Thermotherapy (imILT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Immunostimulating Interstitial Laser Thermotherapy</intervention_name>
    <arm_group_label>imILT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cytohistological diagnosis of ductal pancreatic adenocarcinoma .&#xD;
&#xD;
          -  Stage III disease (see above).&#xD;
&#xD;
          -  The patient is not a candidate for continued chemotherapy or (chemo)radiotherapy due&#xD;
             to lack of demonstrable efficiency or to the side effects of the drugs.&#xD;
&#xD;
          -  Age between 18 and 80 years.&#xD;
&#xD;
          -  Anticipated compliance with treatment and follow-up.&#xD;
&#xD;
          -  Double informed consent for both imILT and possible surgery with radical intent (in&#xD;
             the event of pre-operative overstaging).&#xD;
&#xD;
          -  At least a part of the tumor can be treated with imILT without damage to surrounding&#xD;
             vital structures.&#xD;
&#xD;
          -  Have an ECOG performance status &lt; 1 (l'Eastern Cooperative Oncology Group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a candidate for laparotomy.&#xD;
&#xD;
          -  Becoming resectable after neoadjuvant chemotherapy.&#xD;
&#xD;
          -  Other simultaneous treatments for the same neoplasm.&#xD;
&#xD;
          -  Simultaneous other malignancies except for basal cell carcinoma.&#xD;
&#xD;
          -  HIV positive.&#xD;
&#xD;
          -  Active autoimmune disease.&#xD;
&#xD;
          -  Systemic corticosteroid medication.&#xD;
&#xD;
          -  Pregnancy or nursing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut J. Paoli et L. Calmettes (IPC)</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperthermia, Induced</keyword>
  <keyword>Laser Coagulation</keyword>
  <keyword>Laser Therapy</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT02973217
org study id: CTP-2015-008
nct id: NCT02973217
lead sponsor: 
has dmc: Yes
Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.
      Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of
      thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a
      tumor specific immunologic response. In laboratory animals the imILT method has also been
      shown to induce a so called abscopal effect. This means that when one tumor is treated with
      imILT other, untreated, tumors also decrease in size.

      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction
      of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is
      also to investigate the functionality and safety as well as understanding of the subsequent
      immunological effects.

      This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic
      cancer will be treated in this trial, which is estimated to be carried out during a time
      period of 36 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety (adverse events)
time frame: 36 months
description: Evaluation of adverse events.
measure: Inflammatory response in circulation measured by quantification of inflammatory cell populations
time frame: 36 months
description: Quantification of cellular infiltrate and activation markers by flow cytometry.
measure: Disease progression
time frame: 36 months
description: Analysis of the percentage of patients with no new oncological events.
measure: Evaluation of Quality of Life (using questionnaires)
time frame: 36 months
description: Evaluation of Quality of Life is evaluated using standardized questionnaires.
measure: Usability of the device as evaluated by treatment logs
time frame: 36 months
description: Evaluation of the laser system by analysis of treatment logs of the device.
arm group label: imILT
arm group type: Experimental
description: Immunostimulating Interstitial Laser Thermotherapy (imILT)
intervention type: Device
intervention name: Immunostimulating Interstitial Laser Thermotherapy
arm group label: imILT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No