Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Clinical Laserthermia Systems AB5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms Pancreatic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety (adverse events)

Evaluation of adverse events.

Time frame: 36 months

Secondary Outcomes

Inflammatory response in circulation measured by quantification of inflammatory cell populations

Quantification of cellular infiltrate and activation markers by flow cytometry.

Time frame: 36 months

Disease progression

Analysis of the percentage of patients with no new oncological events.

Time frame: 36 months

Evaluation of Quality of Life (using questionnaires)

Evaluation of Quality of Life is evaluated using standardized questionnaires.

Time frame: 36 months

Usability of the device as evaluated by treatment logs

Evaluation of the laser system by analysis of treatment logs of the device.

Time frame: 36 months

Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes