Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

December 16, 2020 updated by: Clinical Laserthermia Systems AB

Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • Institut J. Paoli et L. Calmettes (IPC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cytohistological diagnosis of ductal pancreatic adenocarcinoma .
  • Stage III disease (see above).
  • The patient is not a candidate for continued chemotherapy or (chemo)radiotherapy due to lack of demonstrable efficiency or to the side effects of the drugs.
  • Age between 18 and 80 years.
  • Anticipated compliance with treatment and follow-up.
  • Double informed consent for both imILT and possible surgery with radical intent (in the event of pre-operative overstaging).
  • At least a part of the tumor can be treated with imILT without damage to surrounding vital structures.
  • Have an ECOG performance status < 1 (l'Eastern Cooperative Oncology Group)

Exclusion Criteria:

  • Not a candidate for laparotomy.
  • Becoming resectable after neoadjuvant chemotherapy.
  • Other simultaneous treatments for the same neoplasm.
  • Simultaneous other malignancies except for basal cell carcinoma.
  • HIV positive.
  • Active autoimmune disease.
  • Systemic corticosteroid medication.
  • Pregnancy or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: imILT
Immunostimulating Interstitial Laser Thermotherapy (imILT)
Device: Immunostimulating Interstitial Laser Thermotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (adverse events)
Time Frame: 36 months
Evaluation of adverse events.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory response in circulation measured by quantification of inflammatory cell populations
Time Frame: 36 months
Quantification of cellular infiltrate and activation markers by flow cytometry.
36 months
Disease progression
Time Frame: 36 months
Analysis of the percentage of patients with no new oncological events.
36 months
Evaluation of Quality of Life (using questionnaires)
Time Frame: 36 months
Evaluation of Quality of Life is evaluated using standardized questionnaires.
36 months
Usability of the device as evaluated by treatment logs
Time Frame: 36 months
Evaluation of the laser system by analysis of treatment logs of the device.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Laserthermia Systems AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

April 29, 2019

Study Completion (Actual)

July 22, 2019

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 25, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTP-2015-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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