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Hepatocellular CarcinomaNCT02828865

A Clinical Trial Using Irreversible Electroporation for the Treatment of Liver Cancers

A study testing Irreversible Electroporation (IRE) System in people with Hepatocellular Carcinoma and Metastatic Liver Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Irreversible Electroporation (IRE) System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteTaiwan
Study dates
Nov 2012to 27 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria to be eligible for this study:
  • The diagnosis of hepatocellular carcinoma (HCC) or metastatic liver cancers with pathologic proven, and the diagnosis of HCC will be made by pathology / cytology or according to the American Association for the Study of Liver Diseases (AASLD) (2010) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either tri-phase multidetector computed tomography (CT) scan or dynamic contrast enhanced magnetic resonance imaging (MRI). If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including cluster of differentiation 34 (CD34), cytokeratin 7 (CK7), glypican 3, heat shock protein 70 (HSP70), and glutamine synthetase to improve diagnostic accuracy.
  • Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 5 mm.
  • Have at least one, but less than or equal to 3 tumors,
  • Each tumor must be ≤ 5 cm in diameter,
  • Child-Pugh class A-B,
Show all 12Show fewer
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  • American Society of Anaesthesiologists (ASA) score ≤ 3,
  • Adequate bone marrow, liver and renal function. Platelet count ≥ 100 K/Μl. Total bilirubin ≦ 2 mg/dL. alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal. prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0. Serum creatinine ≦ 1.5 x upper limit of normal
  • Prior Informed Consent Form
  • Life expectancy of at least 3 months.
  • The disease status is not suitable to receive surgical resection, percutaneous alcohol injection, transarterial chemoembolization or other standard treatment.

Who cannot join

  • Patients presenting with any of the following will not be enrolled into this study:
  • 1. History of cardiac disease:
  • Congestive heart failure >New York Heart Association (NYHA) class 2
  • Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
  • Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
  • Uncontrolled hypertension 2. Any active metal implanted device (eg Pacemaker), 3. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, 4. Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the IRE System, 5. Known history of HIV infection 6. Concurrent extrahepatic cancer

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

About this study

Official title: A Prospective Clinical Trial Using Irreversible Electroporation for the Treatment of Liver Cancers

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes.

Read the detailed description

Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor effect does not result from thermotherapy, so is also not diminished by adjacent vessels. Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment for live cancers. The system has been approved as safe by the European Union (EU) in 2008 and received Food and Drug Administration (FDA) approval in 2010. However, there are still few experiences in using IRE for tumor ablation in Taiwan. In this study, the investigators will perform IRE for 40 inoperable patients with liver cancers adjacent to vessels who are suitable to receive radiofrequency ablation (RFA) in the investigators hospital. The investigators will evaluate the potential side effect and ablate effect of tumors by abdominal computed tomography (CT) or magnetic resonance imaging (MRI), and the investigators will also follow-up this patients for 2 years to evaluate the overall survival and local recurrence rate. The investigators will appraisal the clinical feasibility and advantage of the system by this study.

Being tested
Irreversible Electroporation (IRE) System
Keywords
Hepatocellular Carcinoma, irreversible electroporation, liver cancer
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irreversible Electroporation (IRE) SystemDevice

Study groups in NCT02828865
Study groupRoleWhat they receive
irreversible electroporation (IRE)Experimentalirreversible electroporation (IRE) (AngioDynamics, NY) To use 2 to 6 unipolar electrodes of IRE in a predetermined grid pattern. 90 pulses of 2,000 - 3,000 V were applied with a pulse generator (AngioDynamics, NY) across the gap between the electrodes for 100 microseconds (0.1 msec) per each ablation.
Receives: Device: Irreversible Electroporation (IRE) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response

    Tumor response, according to modified RECIST criteria, will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI) 1 month after treatment.

    Measured: 1 month after treatment

Secondary outcomes (8)

  1. Change of Eastern Cooperative Oncology Group (ECOG) evaluation

    Complete an Eastern Cooperative Oncology Group (ECOG) evaluation

    Measured: one to two years

  2. Change of vital signs

    Measure vital signs including temperature, respiratory rate, blood pressure, and heart rate.

    Measured: one to two years

  3. Physical examination

    Conduct a physical examination.

    Measured: one to two years

  4. Clinical laboratory assessments

    Collect blood samples for Clinical laboratory assessments, including hematology, A-fetoprotein (AFP) (for hepatocellular carcinoma (HCC)) / carcinoembryonic antigen (CEA) (for adenocarcinoma) and chemistry evaluations.

    Measured: one to two years

  5. Urinalysis

    Collect urine sample for a routine urinalysis.

    Measured: one to two years

  6. Conduct CT or MR scans for tumour response evaluation

    Subjects will still be followed-up in the event of disease progression in order to document local recurrence, a secondary endpoint.

    Measured: one to two years

  7. Review concomitant medications

    Use of medications will be reviewed and recorded.

    Measured: one to two years

  8. Assess for presence of adverse events

    An adverse event assessment will be performed.

    Measured: one to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2016 (estimated)
  2. Study startNov 2012
  3. Primary completion18 Dec 2013
  4. Study completion27 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02828865
Sponsor's protocol ID
201210007DIC
Status last verified
Jul 2020
First submitted
27 Jun 2016
Last updated
7 Jul 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Irreversible Electroporation (IRE) System in people with Hepatocellular Carcinoma and Metastatic Liver Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response (time frame: 1 month after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02828865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.

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