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

Pancreatic Cancer Clinical Trial

Official title:

Immunostimulating Interstitial Laser Thermotherapy in Patients With Locally Advanced Pancreatic Cancer: Results of a Prospective, Open, Non Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702986
• Other study ID #: CTP-2015-001
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: October 2021

Study information

• Verified date: April 2022
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• immunostimulating Interstitial Laser Thermotherapy
Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.

Device:
• Laser

Locations

Country	Name	City	State
Italy	University of Verona Hospital	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	Clinical Laserthermia Systems AB

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Haraldsdóttir 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. — View Citation

Ivarsson K, Myllymäki 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. — View Citation

Ivarsson K, Myllymäki 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. — View Citation

Tranberg KG, Möller PH, Hannesson P, Stenram U. Interstitial laser treatment of malignant tumours: initial experience. Eur J Surg Oncol. 1996 Feb;22(1):47-54. — View Citation

Tranberg KG, Myllymäki L, Möller PH, Ivarsson K, Sjögren HO, Stenram U. Interstitial laser thermotherapy of a rat liver adenocarcinoma. J Xray Sci Technol. 2002 Jan 1;10(3):177-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		Up to 24 months
Secondary	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
Secondary	Overall Survival		Up to 24 months
Secondary	Progression free survival (PFS)		Up to 24 months
Secondary	Disease specific survival (DSS)		Up to 24 months