Treatment of Primary Liver Tumors With Electrochemotherapy (ECT) (ECT-HCC)
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|ClinicalTrials.gov Identifier: NCT02291133|
Recruitment Status : Unknown
Verified November 2014 by Miha Žemlja, University Medical Centre Ljubljana.
Recruitment status was: Recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Procedure: Electrochemotherapy Device: Cliniporator Vitae® Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP)||Phase 1 Phase 2|
The study will be conducted on patients with primary liver tumors. 10 patients will be included in phase I clinical study and additional 15 patients in phase II clinical study (or in the extension of the clinical study).
Depending on the position of tumors, appropriate electrodes will be selected; hexagonal needle electrodes with fixed geometry for tumors not larger than 3 cm in diameter, where lower edge of the tumor is located up to 3 cm below the liver capsule or longer single needle electrodes. Individual electrodes, positioned according to the prepared treatment plan will be used for tumors up to 7 cm in diameter, or located near vena cava or large hepatic or portal veins.
Electrochemotherapy will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2).
Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.
All patients will be treated after the procedure has been thoroughly described to them, and have signed informed consent.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||July 2017|
- 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)
- Evaluation of toxicity related to electrochemotherapy (toxicity, symptoms) Biochemistry, blood test and/or US [ Time Frame: After operation on day 7 ]Biochemistry, blood test and/or US
- Change from baseline, clinical response evaluation [ Time Frame: After operation on days 1, 7, 30, 60, 90, 120 ]Biochemistry, blood test, CT and/or DCE-US
- Changes in tumor size and structure by -DCE-US or CT perfusion, to detect early events in tumor perfusion, Modified RECIST criteria as well as Modified Choi criteria evaluation of long term effectiveness, based on CT perfusion and/or MRI [ Time Frame: After operation on the days 30, 60 and 120 ]Imaging methods for the evaluation of the treated lesions in the liver.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291133
|Contact: Gregor Sersa, PhDemail@example.com|
|Contact: Borut Stabuc, MD, PhDfirstname.lastname@example.org|
|University Medical Centre Ljubljana, Ljubljana, Slovenia||Recruiting|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Mihajlo Djokic, MD||University Medical Centre Ljubljana, Ljubljana, Slovenia|
|Principal Investigator:||Blaz Trotovsek, MD, PhD||University Medical Centre Ljubljana, Ljubljana, Slovenia|
|Study Director:||Gregor Sersa, PhD||Institute of Oncology Ljubljana, Slovenia|
|Study Director:||Borut Stabuc, MD, PhD||University Medical Centre Ljubljana, Ljubljana, Slovenia|
|Study Chair:||Dragoje Stanisavljevic, MD||University Medical Centre Ljubljana, Ljubljana, Slovenia|
|Study Chair:||Valentin Sojar, MD, PhD||University Medical Centre Ljubljana, Ljubljana, Slovenia|