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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
immunostimulating Interstitial Laser Thermotherapy
Laser
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Verona Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

imILT of pancreatic cancer

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

The immunostimulating effects of imILT
This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells
Overall Survival
Progression free survival (PFS)
Disease specific survival (DSS)

Full Information

First Posted
February 14, 2016
Last Updated
April 19, 2022
Sponsor
Universita di Verona
Collaborators
Clinical Laserthermia Systems AB
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1. Study Identification

Unique Protocol Identification Number
NCT02702986
Brief Title
Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC)
Official Title
Immunostimulating Interstitial Laser Thermotherapy in Patients With Locally Advanced Pancreatic Cancer: Results of a Prospective, Open, Non Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 2021 (Actual)
Study Completion Date
October 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
Collaborators
Clinical Laserthermia Systems AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
imILT of pancreatic cancer
Arm Type
Experimental
Arm Description
10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting
Intervention Type
Procedure
Intervention Name(s)
immunostimulating Interstitial Laser Thermotherapy
Other Intervention Name(s)
imILT
Intervention Description
Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.
Intervention Type
Device
Intervention Name(s)
Laser
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
The immunostimulating effects of imILT
Description
This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells
Time Frame
Up to 24 months
Title
Overall Survival
Time Frame
Up to 24 months
Title
Progression free survival (PFS)
Time Frame
Up to 24 months
Title
Disease specific survival (DSS)
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of stage III locally advanced pancreatic cancer No further neoadjuvant treatments are doable Eastern Cooperative Oncology Group performance status < 1 Exclusion Criteria: No other concomitant oncological treatments (hormonal, immunotherapies, etc) Suffering from other neoplasms Suffering from HIV Suffering from autoimmune diseases Concomitant medication with steroids
Facility Information:
Facility Name
University of Verona Hospital
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21400025
Citation
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.
Results Reference
result
PubMed Identifier
16091763
Citation
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.
Results Reference
result
PubMed Identifier
8846867
Citation
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.
Results Reference
result
PubMed Identifier
22388047
Citation
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.
Results Reference
result
PubMed Identifier
14666667
Citation
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.
Results Reference
result
PubMed Identifier
33278792
Citation
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.
Results Reference
derived

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

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