ClinicalTrials.gg
Not yet recruitingNCT07192731LIVERHCC-IREUpdated Oct 10, 2025

International Study on Treatment of Liver (HCC) Patients With IRE

An interventional study of Irreversible Electroporation in Hepatocellular Carcinoma (HCC), Liver Ablation and Liver Cancer, Adult, sponsored by Angiodynamics, Inc.. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.

Sponsored by Angiodynamics, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation

02

Conditions studied

  • Hepatocellular Carcinoma (HCC)
  • Liver Ablation
  • Liver Cancer, Adult

Keywords

  • irreversible electroporation
  • liver ablation
  • nanoknife
  • liver ire registry
03

In context

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

This study's planned enrollment of 50 is close to the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Angiodynamics, Inc. is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years and over, able to provide and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study.
  • A up to A6.
  • Eastern Co-operative Oncology Group () Score ≤ 2.
  • Rockwood Frailty Score ≤ 3.
  • Serum \< 30 µmol/L.
  • Serum creatinine \< 150 µmol/L.
  • No extrahepatic
  • IRE can be used for up to 3 tumours \< 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.

Exclusion criteria

Exclusion Criteria:

General:

  • Patients involved in other research studies.
  • Patients under the age of 18 years.
  • Inability to give .
  • Patients who are pregnant.
  • B or C.
  • Patients with an status of > 2 at time of recruitment.
  • Rockwood Frailty Score > 3
  • Impaired renal function (serum creatinine > 150 µmol/L)
  • Accepted exclusions to IRE from consensus criteria including:
  • count \< 50x109 U/L.
  • (INR) for blood clotting > 1.7.
  • Prior hepatic tumour ablation.

Cardiovascular fitness related exclusions:

  • History of ventricular arrhythmia.
  • Implanted pacemaker or defibrillator.
  • Congestive cardiac failure Class ≥ 3.

Tumour-related exclusions:

  • Tumour ≥ 3 cm in size.
  • Extrahepatic disease.
  • Jaundice (serum > 30 µmol/L).
  • MDT recommends use of thermal ablation for any given lesion.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Other: Use of NanoKnife System for ablation of HCC lesions

    Device: Irreversible Electroporation

Interventions

  • DeviceIrreversible Electroporation

    Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death. IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.

    Also known as: nanoknife

06

What researchers measure

Primary outcomes

  1. Target Tumour Eradication

    The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria. This is based on a per-lesion analysis.

    Time frame: 6 months

Secondary outcomes

  1. Complications of IRE: Episode-related complications:

    Episode-related complications of IRE using the Clavien-Dindo system and the comprehensive complication index (CCI)

    Time frame: 30 days

  2. Complications of IRE: Intervention for local liver-related complications of IRE

    Any intervention for local liver-related complications of IRE within 12 months of procedure. Interventions will be categorised as radiological, surgical or medical.

    Time frame: 12 months

  3. Oncological outcomes: Incomplete ablation requiring further intervention

    Re-ablation and modality.

    Time frame: 6 months

  4. Oncological Outcome: Progression at site of ablation

    Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up.

    Time frame: 12 months

  5. Oncological outcome: Further anti-cancer intervention

    Any further liver-directed, anti-cancer intervention including TACE and SIRT

    Time frame: 12 months

  6. Oncological Outcome: Survival (Progression-free & overall)

    Progression-free and overall survival at 12 months from time of IRE.

    Time frame: 12 months

  7. Oncologic Outcomes: local progression

    Local progression at site of IRE-treated lesion.

    Time frame: 12 months

  8. Oncologic Outcomes: Chemotherapy post-IRE

    Any use of chemotherapy after IRE.

    Time frame: 6 months

  9. Quality of life: EQ-5D-5 pre-procedure

    Effect of intervention on quality of life as assessed by EQ-5D-5

    Time frame: within 7 days prior to procedure

  10. Quality of life: EQ-5D-5 post-procedure 7 days

    Effect of intervention on quality of life as assessed by EQ-5D-5

    Time frame: 7 days

  11. Quality of life: EQ-5D-5 - 6 months

    Effect of intervention on quality of life as assessed by EQ-5D-5

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2026; primary completion for Feb 2028, 24 months later.

Of 384 interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 75. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2025
First posted
Sep 25, 2025
StartEst.
Feb 2026
Primary completionEst.
Feb 2028
CompletionEst.
Feb 2029
Last update
Oct 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07192731
Responsible party
Sponsor
First posted
Sep 25, 2025
Start date
Feb 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2029 (estimated)
Last update
Oct 10, 2025

Study contacts

Mitchell Vanderpoll
Contact
mvanderpoll@angiodynamics.com
+44 7790921819
Ajith Siriwardena, MD FRCS
principal investigator · Manchester Royal Infirmiary

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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