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

University of Verona

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Procedure: immunostimulating Interstitial Laser Thermotherapy; Device: Laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02702986

CTP-2015-001

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

imILT of pancreatic cancer

Experimental group

Description:

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

Treatment:

Procedure: immunostimulating Interstitial Laser Thermotherapy

Device: Laser