Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Status:
Completed
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
Summary
The study is prospective, phase II study, The primary objective of the study is evaluation of
the feasibility and safety of intraoperative electrochemotherapy of colorectal liver
metastases. The secondary objective is to determine the efficacy of electrochemotherapy
treatment, based on histological and radiological evaluation of treated metastases. The
endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events
(CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST
criteria.
Phase:
Phase 2
Details
Lead Sponsor:
Institute of Oncology Ljubljana
Collaborators:
University Medical Centre Ljubljana University Medical Centre Maribor University of Ljubljana