Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

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Ingia / Ingia

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HaliInatumika, sio kuajiri

Wadhamini

Clinical Laserthermia Systems AB

JARIBIO LA KLINIKI: NCT02973217

BioSeek: nct02973217

Maneno muhimu

Kikemikali

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.

Tarehe

Imethibitishwa Mwisho:	12/31/2018
Iliyowasilishwa Kwanza:	11/21/2016
Uandikishaji uliokadiriwa Uliwasilishwa:	11/21/2016
Iliyotumwa Kwanza:	11/24/2016
Sasisho la Mwisho Liliwasilishwa:	01/28/2019
Sasisho la Mwisho Lilichapishwa:	01/29/2019
Tarehe halisi ya kuanza kwa masomo:	09/30/2016
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	09/30/2020
Tarehe ya Kukamilisha Utafiti:	01/31/2021

Hali au ugonjwa

Neoplasms Pancreatic

Uingiliaji / matibabu

Device: imILT

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT)	Device: imILT

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	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.

Matokeo

Hatua za Matokeo ya Msingi

1. Safety (adverse events) [36 months]

Evaluation of adverse events.

Hatua za Matokeo ya Sekondari

1. Inflammatory response in circulation measured by quantification of inflammatory cell populations [36 months]

Quantification of cellular infiltrate and activation markers by flow cytometry.

2. Disease progression [36 months]

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

3. Evaluation of Quality of Life (using questionnaires) [36 months]

Evaluation of Quality of Life is evaluated using standardized questionnaires.

4. Usability of the device as evaluated by treatment logs [36 months]

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