Safety And Feasibility Of ImILT Locally Advanced Pancreatic Cancer (LAPC)

Study Overview

Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC)

10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated as primary objective. Secondary objectives will be QoL after imILT, study of the immune reaction after imILT, oncological analysis of patients suffering from LAPC submitted to imILT.

N/A

Pancreatic Cancer

PROCEDURE: immunostimulating Interstitial Laser Thermotherapy
DEVICE: Laser

CTP-2015-001

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
First Submitted 2016-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-04-19
First Submitted that Met QC Criteria 2016-03-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-21
First Posted (ACTUAL) 2016-03-09	Results First Posted N/A	Last Verified 2022-04

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: imILT of pancreatic cancer 10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting	PROCEDURE: immunostimulating Interstitial Laser Thermotherapy Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer. DEVICE: Laser

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: imILT of pancreatic cancer

10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting

PROCEDURE: immunostimulating Interstitial Laser Thermotherapy

Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.

DEVICE: Laser

Primary Outcome Measures	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
The immunostimulating effects of imILT	This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells	Up to 24 months
Overall Survival		Up to 24 months
Progression free survival (PFS)		Up to 24 months
Disease specific survival (DSS)		Up to 24 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:

Diagnosis of stage III locally advanced pancreatic cancer
No further neoadjuvant treatments are doable
Eastern Cooperative Oncology Group performance status < 1

No other concomitant oncological treatments (hormonal, immunotherapies, etc)
Suffering from other neoplasms
Suffering from HIV
Suffering from autoimmune diseases
Concomitant medication with steroids

Collaborators and Investigators

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

Clinical Laserthermia Systems AB

Investigators

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

Haraldsdottir KH, Ivarsson K, Jansner K, Stenram U, Tranberg KG. Changes in immunocompetent cells after interstitial laser thermotherapy of breast cancer. Cancer Immunol Immunother. 2011 Jun;60(6):847-56. doi: 10.1007/s00262-011-0992-8. Epub 2011 Mar 13.
Ivarsson K, Myllymaki L, Jansner K, Stenram U, Tranberg KG. Resistance to tumour challenge after tumour laser thermotherapy is associated with a cellular immune response. Br J Cancer. 2005 Aug 22;93(4):435-40. doi: 10.1038/sj.bjc.6602718.
Tranberg KG, Moller PH, Hannesson P, Stenram U. Interstitial laser treatment of malignant tumours: initial experience. Eur J Surg Oncol. 1996 Feb;22(1):47-54. doi: 10.1016/s0748-7983(96)91451-1.
Tranberg KG, Myllymaki L, Moller PH, Ivarsson K, Sjogren HO, Stenram U. Interstitial laser thermotherapy of a rat liver adenocarcinoma. J Xray Sci Technol. 2002 Jan 1;10(3):177-85.
Ivarsson K, Myllymaki L, Jansner K, Bruun A, Stenram U, Tranberg KG. Heat shock protein 70 (HSP70) after laser thermotherapy of an adenocarcinoma transplanted into rat liver. Anticancer Res. 2003 Sep-Oct;23(5A):3703-12.
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.

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