Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Neoplasms Pancreatic

Intervention / Treatment
-----------------
* Device: Immunostimulating Interstitial Laser Thermotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imILT<br>Immunostimulating Interstitial Laser Thermotherapy (imILT) | Device: Immunostimulating Interstitial Laser Thermotherapy<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperthermia, Induced, Laser Coagulation, Laser Therapy