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

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasms Pancreatic
• Intervention / Treatment: Device: imILT; Drug: Standard chemotherapy treatment

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-072
    • Portuguese Oncology Institute of Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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:

  1. Hemoglobin ≥9 g/dL
  2. Platelet count ≥75 x 109/L
  3. International normalized ratio (INR) ≤1.7
  4. WBC count ≥2 x 109/L
  5. Absolute neutrophil count (ANC) ≥1 x 109/L
  6. Albumin ≥2.8 g/dL, total bilirubin ≤3.0 mg/dL (51.3 μmol/L); ALT, AST ≤5 times upper limit of normal (ULN)
  7. Serum chemistries sodium, potassium, and calcium within normal limits (WNL)
  8. Serum creatinine <2.0 mg/dL or creatinine clearance >60 mL/min according to Cockroft-Gault formula
• At least a part of the tumour can be treated with imILT without damage to adjacentvital structures
• Have an ECOG performance status <2 (Karnofsky> 60%)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: imILT treatment; Immunostimulating Interstitial Laser Thermotherapy (imILT)	Device: imILT; The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.; Other Names: TRANBERG Thermal Therapy System
Active Comparator: Standard chemotherapy treatment; This study arm recieves chemotherapy treatment as standard care at the clinical study site.	Drug: Standard chemotherapy treatment; The standard chemotherapy treamtment arm recieves only chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment effect by radiology	Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by the incidence the of adverse events	Evaluation of adverse events and laboratory analyses.	12 months
Usability (user evaluation of instrument)	Analysis of instrument and user questionnaires relating to the ease of use.	12 months

Collaborators and Investigators

• Sponsor: Clinical Laserthermia Systems AB
• Investigators: Principal Investigator: Belarmino Goncalves, MD, Portuguese Oncology Institute of Porto

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Laser Therapy; Laser Coagulation; Hyperthermia, Induced
• Other Study ID Numbers: CTP-2015-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No