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Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC)

Sponsor
Universita di Verona (Other)
Overall Status
Completed
CT.gov ID
NCT02702986
Collaborator
Clinical Laserthermia Systems AB (Industry)
10
Enrollment
1
Location
1
Arm
68
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated as primary objective. Secondary objectives will be QoL after imILT, study of the immune reaction after imILT, oncological analysis of patients suffering from LAPC submitted to imILT.

Condition or Disease Intervention/Treatment Phase
  • Procedure: immunostimulating Interstitial Laser Thermotherapy
  • Device: Laser
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immunostimulating Interstitial Laser Thermotherapy in Patients With Locally Advanced Pancreatic Cancer: Results of a Prospective, Open, Non Comparative Study
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: imILT of pancreatic cancer

10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting

Procedure: immunostimulating Interstitial Laser Thermotherapy
Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.
Other Names:
  • imILT

    • Device: Laser

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Up to 24 months]

    Secondary Outcome Measures

    1. The immunostimulating effects of imILT [Up to 24 months]

      This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells

    2. Overall Survival [Up to 24 months]

    3. Progression free survival (PFS) [Up to 24 months]

    4. Disease specific survival (DSS) [Up to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of stage III locally advanced pancreatic cancer

    • No further neoadjuvant treatments are doable

    • Eastern Cooperative Oncology Group performance status < 1

    Exclusion Criteria:

    • No other concomitant oncological treatments (hormonal, immunotherapies, etc)

    • Suffering from other neoplasms

    • Suffering from HIV

    • Suffering from autoimmune diseases

    • Concomitant medication with steroids

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Verona Hospital Verona Italy 37134

    Sponsors and Collaborators

    • Universita di Verona
    • Clinical Laserthermia Systems AB

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salvatore Paiella, MD, MD, Universita di Verona
    ClinicalTrials.gov Identifier:
    NCT02702986
    Other Study ID Numbers:
    • CTP-2015-001
    First Posted:
    Mar 9, 2016
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Apr 21, 2022