Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Not Applicable

Completed

• Conditions: Neoplasms Pancreatic
• Interventions: Device: Immunostimulating Interstitial Laser Thermotherapy

• Registration Number: NCT02973217
• Lead Sponsor: Clinical Laserthermia Systems AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Primary Completion: 2019-04-29
• Study Completion: 2019-07-22
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imILT	Immunostimulating Interstitial Laser Thermotherapy	Immunostimulating Interstitial Laser Thermotherapy (imILT)

Primary Outcome Measures

Name	Time	Method
Safety (adverse events)	36 months	Evaluation of adverse events.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut J. Paoli et L. Calmettes (IPC); 🇫🇷 Marseille, France