NCT03187587

Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

An Open-Label, Comparative Trial to Evaluate the Effect of imILT in Patients With Advanced Disease or Stage IV Pancreatic Carcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Clinical Laserthermia Systems AB · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 performed pecutaneously in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety of the method. This trial is an open-label, double-arm study. Twenty patients diagnosed with pancreatic cancer will be treated in this trial, ten recieving imILT treatment and ten recieving standard chemotherapy. The study is estimated to be carried out during a time period of 21 months.

Conditions

• Neoplasms Pancreatic

Interventions

Type	Name	Description
DEVICE	imILT	The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.
DRUG	Standard chemotherapy treatment	The standard chemotherapy treamtment arm recieves only chemotherapy.

Timeline

• Start date: 2017-05-17
• Primary completion: 2019-11-25
• Completion: 2020-03-01
• First posted: 2017-06-15
• Last updated: 2021-07-07

Locations

1 site across 1 country: Portugal