CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Bleomycin PHC 15 e. (United States Pharmacopeia - USP) +2 moredrug
Likely dose
Bleomycin PHC 15 e. (United States Pharmacopeia - USP) 15 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02352259
NCT02352259Phase 2Completed
CompareCT.gov

Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II

Institute of Oncology Ljubljana·interventional·Posted Feb 2, 2015·Updated Mar 24, 2021

In Brief

A Phase 2 clinical trial evaluating Electrochemotherapy, Cliniporator Vitae®, and 1 other intervention for Liver Metastases. Completed, enrolled 23 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Metastases
CountriesSlovenia
CollaboratorsUniversity Medical Centre Ljubljana, University Medical Centre Maribor, University of Ljubljana

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2015
Enrollment StartSep 1, 2013
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.4 years ago

Interventions

Electrochemotherapyprocedure

Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin, within 8-30 min after administration of bleomycin application of electric pulses, removal of electrodes.

Cliniporator Vitae®device

Positioning of electrodes, within 8-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.

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

Intravenous in bolus administration of bleomycin (15 mg/m2), 8 minutes before application of electric pulses