Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Clinical Laserthermia Systems (CLS)

Status: Completed

Conditions: Neoplasms Pancreatic

Treatments: Device: Immunostimulating Interstitial Laser Thermotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02973217

CTP-2015-008

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

imILT

Experimental group

Description:

Immunostimulating Interstitial Laser Thermotherapy (imILT)

Treatment:

Device: Immunostimulating Interstitial Laser Thermotherapy