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OpenTrials
Completed

NCT Number: NCT02702986

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

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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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Verona Hospital

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunostimulating Interstitial Laser Thermotherapy

Procedure

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

Other names: imILT

laser

Device

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

    Time frame: Up to 24 months

    This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells

  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

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Collaborators

  • Clinical Laserthermia Systems AB

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2016
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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