Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

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: Neoplasms Pancreatic
• Intervention / Treatment: Device: Immunostimulating Interstitial Laser Thermotherapy

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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	Quantification of cellular infiltrate and activation markers by flow cytometry.	36 months
Disease progression	Analysis of the percentage of patients with no new oncological events.	36 months
Evaluation of Quality of Life (using questionnaires)	Evaluation of Quality of Life is evaluated using standardized questionnaires.	36 months
Usability of the device as evaluated by treatment logs	Evaluation of the laser system by analysis of treatment logs of the device.	36 months

Collaborators and Investigators

• Sponsor: Clinical Laserthermia Systems AB

Publications and helpful links

General Publications

• Paiella S, Casetti L, Ewald J, Marchese U, D'Onofrio M, Garnier J, Landoni L, Gilabert M, Manzini G, Esposito A, Secchettin E, Malleo G, Lionetto G, De Pastena M, Bassi C, Delpero JR, Salvia R, Turrini O. Laser Treatment of Pancreatic Cancer with Immunostimulating Interstitial Laser Thermotherapy Protocol: Safety and Feasibility Results From Two Phase 2a Studies. J Surg Res. 2021 Mar;259:1-7. doi: 10.1016/j.jss.2020.10.027. Epub 2020 Dec 2.

Study record dates

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: Laser Therapy; Laser Coagulation; Hyperthermia, Induced
• Other Study ID Numbers: CTP-2015-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No