Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

NCT ID: NCT02973217

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-07-22

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.

Conditions

Neoplasms Pancreatic

Keywords

Hyperthermia, Induced; Laser Coagulation; Laser Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

imILT

Immunostimulating Interstitial Laser Thermotherapy (imILT)

Group Type: EXPERIMENTAL

Immunostimulating Interstitial Laser Thermotherapy

Intervention Type: DEVICE

Interventions

Immunostimulating Interstitial Laser Thermotherapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Laserthermia Systems AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut J. Paoli et L. Calmettes (IPC)

Marseille, , France

Countries

France

References

Paiella S, Casetti L, Ewald J, Marchese U, D'Onofrio M, Garnier J, Landoni L, Gilabert M, Manzini G, Esposito A, Secchettin E, Malleo G, Lionetto G, De Pastena M, Bassi C, Delpero JR, Salvia R, Turrini O. Laser Treatment of Pancreatic Cancer with Immunostimulating Interstitial Laser Thermotherapy Protocol: Safety and Feasibility Results From Two Phase 2a Studies. J Surg Res. 2021 Mar;259:1-7. doi: 10.1016/j.jss.2020.10.027. Epub 2020 Dec 2.

Reference Type: DERIVED

PMID: 33278792 (View on PubMed)

Other Identifiers

CTP-2015-008

Identifier Type: -

Identifier Source: org_study_id