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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
Sponsor:
Collaborators:
Institute of Oncology Ljubljana
University of Ljubljana
Information provided by (Responsible Party):
Miha Žemlja, University Medical Centre Ljubljana

Brief 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.


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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer


Intervention Details:
  • 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)


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with primary liver tumors; hepatocellular carcinoma, intrahepatic cholangiocarcinoma and other primary tumors not larger than 7 cm that are positioned in unresectable liver area, near blood vessels in operable patients.
  2. Patients with the progression of the disease (confirmed by radiological imaging) after treatment with TACE, RFA or percutaneous alcohol ablation, which are not suitable for potentially curative treatment, but with relatively good "performance status" and Child-Pugh score < 8.

    Patients from group 1. and 2. are patients, in whom standard treatment procedures are not eligible, so ECT will be the only therapeutic option. In patients with multiple liver tumors, unresectable tumors which are also unsuitable for RAF will be treated by ECT, whereas other tumors will be resected or treated by RAF.

  3. Patients with tumors smaller tumors, not suitable for liver transplantation, but also unsuitable for RFA treatment or percutaneous alcohol ablation because of the position of the tumor. Electrochemotherapy will be as bridge therapy, till liver transplantation.
  4. Patients with tumors> 4 cm in diameter, in difficult to reach locations, and patients unsuitable for treatment with other treatment options.

    Patients from group 3. and 4. are patients, potentially curable with standard treatment. Electrochemotherapy in these patients will not affect the standard of care of these patients, recommended in guidelines for HCC.

  5. Electrochemotherapy is offered to the patients also when they refuse standard treatments.
  6. Histologically confirmed primary liver cancer and/or based on radiological imaging laboratory tests confirmed primary liver cancer by multidisciplinary team for liver tumors.
  7. Age more than 18.
  8. Life expectancy more than 3 month.
  9. Performance status Karnofsky ≥ 70 or (World Health Organization) WHO < or 2.
  10. Treatment free interval 2-5 weeks, depending on the drugs used.
  11. Patient must be mentally capable of understanding the information given.
  12. Patient must give informed consent.
  13. Patient must be discussed at the multidisciplinary team for liver tumors before entering the trial.

Exclusion Criteria:

  1. Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma
  2. Visceral, bone or diffuse metastases.
  3. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
  4. Clinically significant ascites.
  5. Significant reduction in respiratory function.
  6. Age less than 18 years.
  7. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
  8. Cumulative dose of 250 mg/m2 bleomycin received.
  9. Allergic reaction to bleomycin.
  10. Impaired kidney function (creatinin > 150 µmol/l).
  11. Patients with epilepsy.
  12. Patients with arrhythmias.
  13. Patients with heart failure or pace maker.
  14. Pregnancy.
  15. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.

Information from the National Library of Medicine

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


Contacts
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Contact: Gregor Sersa, PhD +386-1-5879-434 gsersa@onko-i.si
Contact: Borut Stabuc, MD, PhD borut.stabuc@kclj.si

Locations
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Slovenia
University Medical Centre Ljubljana, Ljubljana, Slovenia Recruiting
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Institute of Oncology Ljubljana
University of Ljubljana
Investigators
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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

Publications:
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Responsible Party: Miha Žemlja, univ. dipl. org. dela, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02291133     History of Changes
Other Study ID Numbers: 21K/02/14
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Miha Žemlja, University Medical Centre Ljubljana:
Primary liver tumors
Bleomycin
Electrochemotherapy

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents