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

NCT ID: NCT02702986

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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imILT of pancreatic cancer

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

Group Type EXPERIMENTAL

immunostimulating Interstitial Laser Thermotherapy

Intervention Type PROCEDURE

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

Laser

Intervention Type DEVICE

Interventions

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immunostimulating Interstitial Laser Thermotherapy

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

Intervention Type PROCEDURE

Laser

Intervention Type DEVICE

Other Intervention Names

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imILT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Laserthermia Systems AB

INDUSTRY

Sponsor Role collaborator

Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Salvatore Paiella, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Verona Hospital

Verona, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 21400025 (View on PubMed)

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.

Reference Type RESULT
PMID: 16091763 (View on PubMed)

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.

Reference Type RESULT
PMID: 8846867 (View on PubMed)

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.

Reference Type RESULT
PMID: 22388047 (View on PubMed)

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.

Reference Type RESULT
PMID: 14666667 (View on PubMed)

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

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CTP-2015-001

Identifier Type: -

Identifier Source: org_study_id

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