Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)

Summary

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of primary liver tumors in clinical study phase I and II.

The study will include 10 patients in phase I clinical study and additional 15 patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.

Treatment effectiveness will be evaluated by DCE-US or CT perfusion, to detect early events in tumor perfusion after ECT compared to tumor perfusion before ECT. Long term effectiveness of the treatment will be evaluated by modified RECIST criteria, which will take into account difference in size and density, determined from images obtained by CT perfusion of the treated tumor nodules before and after ECT. Tumor volume will be calculated by following formula , where a will be shorter and b longer tumor diameter.

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

• Liver Cancer

Interventions

PROCEDURE

Electrochemotherapy

Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation

DEVICE

Cliniporator Vitae®

Positioning of electrodes, 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), removal of electrodes. The maximum duration of procedure is 90 minutes, after liver mobilization.

DRUG

Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Intravenous in bolus administration of bleomycin (15 mg/m2)

Sponsors & Collaborators

• Institute of Oncology Ljubljana

  collaborator OTHER

• University of Ljubljana

  collaborator OTHER

• Masa Bosnjak

  lead OTHER

Principal Investigators

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

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

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

• Borut Stabuc, MD, PhD · University Medical Centre Ljubljana, Ljubljana, Slovenia

• Dragoje Stanisavljevic, MD · University Medical Centre Ljubljana, Ljubljana, Slovenia

• Valentin Sojar, MD, PhD · University Medical Centre Ljubljana, 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

2014-06-30

Primary Completion

2019-09-30

Completion

2020-01-31

Countries

• Slovenia

Study Locations