Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Neoplasms Pancreatic Clinical Trial

Official title:

Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973217
• Other study ID #: CTP-2015-008
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 22, 2019

Study information

• Verified date: December 2020
• Source: Clinical Laserthermia Systems AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 22, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms Pancreatic

Intervention

Device:
• Immunostimulating Interstitial Laser Thermotherapy

Locations

Country	Name	City	State
France	Institut J. Paoli et L. Calmettes (IPC)	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Laserthermia Systems AB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events)	Evaluation of adverse events.	36 months
Secondary	Inflammatory response in circulation measured by quantification of inflammatory cell populations	Quantification of cellular infiltrate and activation markers by flow cytometry.	36 months
Secondary	Disease progression	Analysis of the percentage of patients with no new oncological events.	36 months
Secondary	Evaluation of Quality of Life (using questionnaires)	Evaluation of Quality of Life is evaluated using standardized questionnaires.	36 months
Secondary	Usability of the device as evaluated by treatment logs	Evaluation of the laser system by analysis of treatment logs of the device.	36 months