Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)

Summary

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy (ECT) with bleomycin in pancreatic cancer in clinical study phase I and II. After surgical resection of pancreatic cancer, the posterior resection surface will be treated with ECT with the intention to lower disease recurrence rate.

The study will include 10patients in phase I clinical study and additional 10patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.

Treatment effectiveness will be evaluated by US or CT imaging, to detect early local recurrence of the disease. Long term effectiveness of the treatment will be evaluated by frequent and precise patient follow-up. During follow-up clinical examination, laboratory tests, tumor markers (Ca 19-9 and CEA) and US/CT imaging will be performed.

The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.

Conditions

• Pancreas Cancer

Interventions

PROCEDURE

Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Procedure: Electrochemotherapy Exploration, anesthesia, pancreatic cancer resection, bleomycin administration, electroporation, formation of all anastomoses. Device: Cliniporator Vitae® Positioning of plate electrodes according to landmarks, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization, approximately 1000V/cm), removal of electrodes. The maximum duration of procedure is 90 minutes, after liver mobilization. Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Intravenous bolus administration of bleomycin (15 mg/m2)

Sponsors & Collaborators

• Institute of Oncology Ljubljana

  collaborator OTHER

• University Medical Centre Ljubljana

  lead OTHER

Principal Investigators

• Mihajlo Djokic, MD, PhD · University Medical Centre Ljubljana, Ljubljana, Slovenia

• Blaz Trotovsek, MD, PhD · University Medical Centre Ljubljana, Ljubljana, Slovenia

• Gregor Sersa, PhD · Institute of Oncology, Ljubljana, Slovenia

• Zan Cebron, MD · University Medical Centre Ljubljana, Ljubljana, Slovenia

• Miha Petric, MD · University Medical Centre Ljubljana, Ljubljana, Slovenia

• David Badovinac, MD · University Medical Centre Ljubljana, Ljubljana, Slovenia

• Masa Bosnjak, PhD · Institute of Oncology, Ljubljana, Slovenia

• Bostjan Markelc, PhD · Institute of Oncology, Ljubljana, Slovenia

• Maja Cemazar, PhD · Institute of Oncology, Ljubljana, Slovenia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-13

Primary Completion

2023-05-08

Completion

2026-05-08

Countries

• Slovenia

Study Locations