Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)
Status:
Completed
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Masa Bosnjak University Medical Centre Ljubljana
Collaborators:
Institute of Oncology Ljubljana University of Ljubljana