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CompletedNCT02702986Updated Apr 21, 2022

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

A Phase 1 interventional study of immunostimulating Interstitial Laser Thermotherapy and Laser in Pancreatic Cancer, sponsored by Universita di Verona. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Universita di Verona · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Pancreatic Cancer
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's planned enrollment of 10 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Universita di Verona is the lead sponsor of 122 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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 · Device: Laser

Interventions

  • Procedureimmunostimulating Interstitial Laser Thermotherapy

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

    Also known as: imILT

  • DeviceLaser
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What researchers measure

Primary outcomes

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

    Time frame: Up to 24 months

Secondary outcomes

  1. The immunostimulating effects of imILT

    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

  2. Overall Survival

    Time frame: Up to 24 months

  3. Progression free survival (PFS)

    Time frame: Up to 24 months

  4. Disease specific survival (DSS)

    Time frame: Up to 24 months

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Study locations

1 site
  • University of Verona Hospital
    Verona, 37134, Italy
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References and documents

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. PubMed 21400025 ↗
  • 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. PubMed 16091763 ↗
  • 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. PubMed 8846867 ↗
  • 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. PubMed 22388047 ↗
  • 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. PubMed 14666667 ↗
  • 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. PubMed 33278792 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02702986
Lead sponsor
Universita di Verona
Collaborators
Clinical Laserthermia Systems AB
Responsible party
Salvatore Paiella, MD (MD, Universita di Verona) — Principal investigator
First posted
Mar 9, 2016
Start date
Feb 2016
Primary completion
Oct 2021
Completion
Oct 2021
Last update
Apr 21, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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