Clinical trial NCT02973217: Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer
Official title: Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms Pancreatic
Keywords: Hyperthermia, Induced
Laser Coagulation
Laser Therapy
Lead sponsor: Clinical Laserthermia Systems AB
Sponsor class: INDUSTRY
First posted: 2016-11-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety (adverse events)
timeFrame: 36 months
Secondary outcomes:
measure: Inflammatory response in circulation measured by quantification of inflammatory cell populations
timeFrame: 36 months
measure: Disease progression
timeFrame: 36 months
measure: Evaluation of Quality of Life (using questionnaires)
timeFrame: 36 months
measure: Usability of the device as evaluated by treatment logs
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut J. Paoli et L. Calmettes (IPC)
Study officials:
References:
citation: Paiella S, Casetti L, Ewald J, Marchese U, D'Onofrio M, Garnier J, Landoni L, Gilabert M, Manzini G, Esposito A, Secchettin E, Malleo G, Lionetto G, De Pastena M, Bassi C, Delpero JR, Salvia R, Turrini O. Laser Treatment of Pancreatic Cancer with Immunostimulating Interstitial Laser Thermotherapy Protocol: Safety and Feasibility Results From Two Phase 2a Studies. J Surg Res. 2021 Mar;259:1-7. doi: 10.1016/j.jss.2020.10.027. Epub 2020 Dec 2.