Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

NCT03187587 | Terminated

• 1 other identifier: CTP-2015-006
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyperthermia, Induced; Laser Coagulation; Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Treatment effect by radiology

  Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)

  12 months

Secondary Outcomes (2)

• Safety assessed by the incidence the of adverse events

  12 months

• Usability (user evaluation of instrument)

  12 months

Study Arms (2)

imILT treatment

EXPERIMENTAL

Immunostimulating Interstitial Laser Thermotherapy (imILT)

Device: imILT

Standard chemotherapy treatment

ACTIVE COMPARATOR

This study arm recieves chemotherapy treatment as standard care at the clinical study site.

Drug: Standard chemotherapy treatment

Interventions

imILT DEVICE

The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.

Also known as: TRANBERG Thermal Therapy System

imILT treatment

Standard chemotherapy treatment DRUG

The standard chemotherapy treamtment arm recieves only chemotherapy.

Standard chemotherapy treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of non-resectable pancreatic adenocarcinoma by form of either locally advanced disease (stage II-III) or of stage IV disease with hepatic metastasis (staging according to UICC 2009)
• Locally advanced disease shall have a lesion diameter less than 4cm
• If stage IV disease, the patient shall have only liver metastasis, with less than 5 in number, each one less than 4 cm in diameter
• The patient is a candidate for standard chemotherapy (as described at point 5.1)
• Age between 18 and 80 years, males and females
• Anticipated compliance with treatment and follow-up
• Have given informed verbal and written consent to participation in the trial
• Have stable and adequate haematologic, renal and hepatic functions:
• Hemoglobin ≥9 g/dL
• Platelet count ≥75 x 109/L
• International normalized ratio (INR) ≤1.7
• WBC count ≥2 x 109/L
• Absolute neutrophil count (ANC) ≥1 x 109/L
• Albumin ≥2.8 g/dL, total bilirubin ≤3.0 mg/dL (51.3 μmol/L); ALT, AST ≤5 times upper limit of normal (ULN)
• Serum chemistries sodium, potassium, and calcium within normal limits (WNL)

You may not qualify if:

• HIV 1 or 2 positive
• Active autoimmune disease which is judged to reduce an anti-tumour immune response
• Pregnancy or breast feeding
• Have known bleeding disorder that cannot be managed accordingly with the protocol rules, such severe acute or chronic liver failure, other genetic blood diseases not properly managed prior to treatment or other any disease treated with anticoagulant or anti-platelet medication that cannot be interrupted prior to treatment

Sponsors & Collaborators

• Clinical Laserthermia Systems AB: lead

Study Sites (1)

Portuguese Oncology Institute of Porto

Porto, 4200-072, Portugal

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Hyperthermia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Belarmino Goncalves, MD

  Portuguese Oncology Institute of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: May 17, 2017
• Primary Completion: November 25, 2019
• Study Completion: March 1, 2020
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)