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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02973217
Other study ID # CTP-2015-008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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