Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

• Sponsor: Clinical Laserthermia Systems AB (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02973217
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 33.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Pancreatic	Device: Immunostimulating Interstitial Laser Thermotherapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Apr 29, 2019
• Actual Study Completion Date: Jul 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT)	Device: Immunostimulating Interstitial Laser Thermotherapy

Outcome Measures

Primary Outcome Measures

1. Safety (adverse events) [36 months]

   Evaluation of adverse events.

Secondary Outcome Measures

1. Inflammatory response in circulation measured by quantification of inflammatory cell populations [36 months]

   Quantification of cellular infiltrate and activation markers by flow cytometry.

2. Disease progression [36 months]

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

3. Evaluation of Quality of Life (using questionnaires) [36 months]

   Evaluation of Quality of Life is evaluated using standardized questionnaires.

4. Usability of the device as evaluated by treatment logs [36 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut J. Paoli et L. Calmettes (IPC)	Marseille		France	13009

Sponsors and Collaborators

• Clinical Laserthermia Systems AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinical Laserthermia Systems AB
• ClinicalTrials.gov Identifier: NCT02973217
• Other Study ID Numbers: CTP-2015-008
• First Posted: Nov 25, 2016
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Clinical Laserthermia Systems AB: Hyperthermia, Induced; Laser Coagulation; Laser Therapy

Study Results

No Results Posted as of Dec 17, 2020