NCT02702986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

5.7 years

First QC Date

February 14, 2016

Last Update Submit

April 19, 2022

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

    Up to 24 months

Secondary Outcomes (4)

  • The immunostimulating effects of imILT

    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

Study Arms (1)

imILT of pancreatic cancer

EXPERIMENTAL

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

Procedure: immunostimulating Interstitial Laser ThermotherapyDevice: Laser

Interventions

immunostimulating Interstitial Laser ThermotherapyPROCEDURE

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

Also known as: imILT
imILT of pancreatic cancer
LaserDEVICE
imILT of pancreatic cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Verona Hospital

Verona, 37134, Italy

Location

Related Publications (6)

  • 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.

    PMID: 21400025RESULT

  • 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.

    PMID: 16091763RESULT

  • 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.

    PMID: 8846867RESULT

  • 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.

    PMID: 22388047RESULT

  • 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.

    PMID: 14666667RESULT

  • 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.

    PMID: 33278792DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Lasers

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 14, 2016

First Posted

March 9, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

IT(1)