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Clinical Trial Record

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Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

2017-05-17

2019-11-25

2020-03-01

8

Study Overview

Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

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.

N/A

  • Neoplasms Pancreatic
  • DEVICE: imILT
  • DRUG: Standard chemotherapy treatment
  • CTP-2015-006

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2017-06-13  

N/A  

2021-07-02  

2017-06-14  

N/A  

2021-07-07  

2017-06-15  

N/A  

2021-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: imILT treatment

Immunostimulating Interstitial Laser Thermotherapy (imILT)

DEVICE: imILT

  • The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.
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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Treatment effect by radiologyEvaluation by Response Evaluation Criteria in Solid Tumours (RECIST)12 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Safety assessed by the incidence the of adverse eventsEvaluation 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Belarmino Goncalves, MD, Portuguese Oncology Institute of Porto

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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