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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Procedure: immunostimulating Interstitial Laser Thermotherapy; Device: Laser

• Registration Number: NCT02702986
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-14
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imILT of pancreatic cancer	immunostimulating Interstitial Laser Thermotherapy	10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting
imILT of pancreatic cancer	Laser	10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Up to 24 months

Secondary Outcome Measures

Name	Time	Method
Disease specific survival (DSS)	Up to 24 months
Progression free survival (PFS)	Up to 24 months
The immunostimulating effects of imILT	Up to 24 months	This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells
Overall Survival	Up to 24 months

Trial Locations

Locations (1)

University of Verona Hospital; 🇮🇹 Verona, Italy