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Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

NCT03187587 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-07-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Clinical Laserthermia Systems AB

    lead INDUSTRY

Principal Investigators

  • Belarmino Goncalves, MD · Portuguese Oncology Institute of Porto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2019-11-25
Completion
2020-03-01

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03187587 on ClinicalTrials.gov