Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Straipsnius versti gali tik registruoti vartotojai

Prisijungti Registracija

Nuoroda įrašoma į mainų sritį

StatusasAktyvus, ne verbuojantis

Rėmėjai

Clinical Laserthermia Systems AB

KLINIKINIS TYRIMAS: NCT02973217

BioSeek: nct02973217

Raktažodžiai

Santrauka

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.

Datos

Paskutinį kartą patikrinta:	12/31/2018
Pirmasis pateikimas:	11/21/2016
Numatytas registravimas pateiktas:	11/21/2016
Pirmas paskelbtas:	11/24/2016
Paskutinis atnaujinimas pateiktas:	01/28/2019
Paskutinis atnaujinimas paskelbtas:	01/29/2019
Faktinė studijų pradžios data:	09/30/2016
Numatoma pirminio užbaigimo data:	09/30/2020
Numatoma studijų užbaigimo data:	01/31/2021

Būklė ar liga

Neoplasms Pancreatic

Intervencija / gydymas

Device: imILT

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
Experimental: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT)	Device: imILT

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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.

Rezultatas

Pirminės rezultatų priemonės

1. Safety (adverse events) [36 months]

Evaluation of adverse events.

Antrinės rezultatų priemonės

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.