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NCT Number: NCT02973217

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 in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.

This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut J. Paoli et L. Calmettes (IPC)

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cytohistological diagnosis of ductal pancreatic adenocarcinoma .
  • Stage III disease (see above).
  • The patient is not a candidate for continued chemotherapy or (chemo)radiotherapy due to lack of demonstrable efficiency or to the side effects of the drugs.
  • Age between 18 and 80 years.
  • Anticipated compliance with treatment and follow-up.
  • Double informed consent for both imILT and possible surgery with radical intent (in the event of pre-operative overstaging).
  • At least a part of the tumor can be treated with imILT without damage to surrounding vital structures.
  • Have an ECOG performance status < 1 (l'Eastern Cooperative Oncology Group)

Exclusion criteria

  • Not a candidate for laparotomy.
  • Becoming resectable after neoadjuvant chemotherapy.
  • Other simultaneous treatments for the same neoplasm.
  • Simultaneous other malignancies except for basal cell carcinoma.
  • HIV positive.
  • Active autoimmune disease.
  • Systemic corticosteroid medication.
  • Pregnancy or nursing.

Treatment and study plan

Immunostimulating Interstitial Laser Thermotherapy

Device

Primary outcomes

  1. Safety (adverse events)

    Time frame: 36 months

    Evaluation of adverse events.

Secondary outcomes

  1. Inflammatory response in circulation measured by quantification of inflammatory cell populations

    Time frame: 36 months

    Quantification of cellular infiltrate and activation markers by flow cytometry.

  2. Disease progression

    Time frame: 36 months

    Analysis of the percentage of patients with no new oncological events.

  3. Evaluation of Quality of Life (using questionnaires)

    Time frame: 36 months

    Evaluation of Quality of Life is evaluated using standardized questionnaires.

  4. Usability of the device as evaluated by treatment logs

    Time frame: 36 months

    Evaluation of the laser system by analysis of treatment logs of the device.

Sponsors and collaborators

Lead sponsor

Clinical Laserthermia Systems AB

Industry

Registry information

Official study title

Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2016
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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