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Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDNA

Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

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

NCT02973217•Clinical Laserthermia Systems AB

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Institut J. Paoli et L. Calmettes (IPC)

Marseille, France

Key Dates

Start Date

October 1, 2016

Primary Completion Date

April 29, 2019

Completion Date

July 22, 2019

Last Updated

December 17, 2020

Enrollment

ACTUAL participants

Conditions

Neoplasms Pancreatic

Interventions

Immunostimulating Interstitial Laser Thermotherapy

DEVICE

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COMPLETED

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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