Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

September 30, 2019

Study Completion Date

January 31, 2020

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)

Trial Locations (1)

1000

University Medical Centre Ljubljana, Ljubljana, Slovenia, Ljubljana

All Listed Sponsors
collaborator

Institute of Oncology Ljubljana

OTHER

collaborator

University of Ljubljana

OTHER

lead

Masa Bosnjak

OTHER

NCT02291133 - Treatment of Primary Liver Tumors With Electrochemotherapy (ECT) | Biotech Hunter | Biotech Hunter