Colorectal Adenocarcinoma Metastatic in the LiverLIVERMET-IRENCT07191548
International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE
A study testing Irreversible Electroporation in people with Colorectal Adenocarcinoma Metastatic in the Liver and Liver Ablation, run by Angiodynamics, Inc. at 1 site in United Kingdom.
Trial summary
Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma Metastatic in the Liver, Liver Ablation, Liver Cancer, Adult
- What is being tested?
- Irreversible Electroporation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.
- Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.
- Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
- Rockwood Frailty Score ≤ 3.
- Serum bilirubin < 30 µmol/L.
- Serum creatinine < 150 µmol/L.
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- Up to two lung metastases (< 2cm in size permitted at enrolment).
- Prior treatment with at least one course of systemic chemotherapy (± biologic agent) mandated. Chemotherapy protocol is not specified and is at clinician discretion.
- Primary rectal tumour can remain in situ treated with radiotherapy/chemoradiotherapy according to tumour board recommendations. Primary colonic tumour can remain in situ.
- No prior hepatic tumour ablation
Who cannot join
- Patients involved in other research studies.
- Inability to give informed consent.
- Patients who are pregnant.
- Accepted exclusions to IRE from consensus criteria including:
- Platelet count < 50x109 U/L.
- International normalised ratio (INR) for blood clotting > 1.7.
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- Prior hepatic tumour ablation.
- Cardiovascular fitness related exclusions:
- History of ventricular arrhythmia.
- Implanted pacemaker or defibrillator.
- Congestive cardiac failure NYHA Class ≥ 3.
- Tumour-related exclusions:
- Tumour ≥ 4 cm in size.
- Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, > 2 lung metastases, all segment involvement multiple liver metastases.
- Jaundice (serum bilirubin > 30 µmol/L).
- MDT/tumour recommends use of thermal ablation instead of IRE for any given lesion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Manchester Royal Infirmiary
Manchester, M13 9WL
Ajith Siriwardena, MD FRCS, +44, ajith.siriwardena@mft.nhs.uk
About this study
Official title: Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.
Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.
- Being tested
- Irreversible Electroporation
- Keywords
- irreversible electroporation, liver ablation, metastatic liver disease, nanoknife, liver ire registry
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible ElectroporationDevice
Also called nanoknife
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.
| Study group | Role | What they receive |
|---|---|---|
| Use of NanoKnife System for ablation of metastatic colorectal lesions | Experimental | Not described Receives: Device: Irreversible Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Tumour Eradication
The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria.
Measured: 6 months
Secondary outcomes (11)
Complications of IRE: Episode-related complications:
All complications recorded during inpatient stay recorded using Clavien-Dindo and CCI
Measured: 30 days
Complications of IRE: Intervention for local liver-related complications of IRE
Intervention for local liver-related complications of IRE within 12 months of the procedure categorised as radiological, surgical or medical
Measured: 12 months
Oncological outcomes: Local progression at site of IRE-treated lesion
Local progression at site of IRE-treated lesion
Measured: 12 months
Oncological Outcomes: Re-ablation and modality.
Re-ablation and modality.
Measured: 12 months
Oncological Outcomes: New lesions
Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up.
Measured: 12 months
Oncological Outcomes: Post IRE Chemotherapy
Any use of chemotherapy after IRE
Measured: 12 months
Oncological Outcomes: Other liver-directed interventions
Any further liver-directed, anti-cancer intervention including surgery and radiotherapy.
Measured: 12 months
Oncological Outcomes: Disease-free and overall survival from time of IRE.
Disease-free and overall survival from time of IRE.
Measured: 12 months
Quality of life - pre procedure
EQ-5D-5L survey
Measured: pre procedure up to 7 days
Quality of life - 7 days follow-up
EQ-5D-5L survey
Measured: 7 days
Quality of life - 6 months
EQ-5D-5L survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Adenocarcinoma Metastatic in the LiverStudies of the same condition, open and under way.
- More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- This is an international, prospective, multi-centre, registry-based, non-randomized, single arm, clinical cohort study of the use of IRE for the treatment of liver metastases from colorectal cancer in patients who have received systemic chemotherapy.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajith Siriwardena, MD FRCS, Principal investigator, Manchester Royal Infirmiary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191548
- Sponsor's protocol ID
- 2025-ONC-01
- Acronym
- LIVERMET-IRE
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.
- ClinicalTrials.gov ID
- NCT07191548
- Acronym / sponsor ID
- LIVERMET-IRE / 2025-ONC-01
- Keywords
- irreversible electroporation, liver ablation, metastatic liver disease, nanoknife, liver ire registry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an international, prospective, multi-centre, registry-based, non-randomized, single arm, clinical cohort study of the use of IRE for the treatment of liver metastases from colorectal cancer in patients who have received systemic chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Use of NanoKnife System for ablation of metastatic colorectal lesions | Experimental | Device: Irreversible Electroporation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.
- Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.
- Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
- Rockwood Frailty Score ≤ 3.
- Serum bilirubin < 30 µmol/L.
Key exclusion criteria (16 listed)
- Patients involved in other research studies.
- Inability to give informed consent.
- Patients who are pregnant.
- Accepted exclusions to IRE from consensus criteria including:
- Platelet count < 50x109 U/L.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible ElectroporationAlso: nanoknifeIrreversible 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. | Device | Use of NanoKnife System for ablation of metastatic colorectal lesions |
Primary outcome
Target Tumour Eradication
Time frame: 6 months
The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria.
11 secondary outcomes
Complications of IRE: Episode-related complications:
Time frame: 30 days
Complications of IRE: Intervention for local liver-related complications of IRE
Time frame: 12 months
Oncological outcomes: Local progression at site of IRE-treated lesion
Time frame: 12 months
Oncological Outcomes: Re-ablation and modality.
Time frame: 12 months
Oncological Outcomes: New lesions
Time frame: 12 months
Oncological Outcomes: Post IRE Chemotherapy
Time frame: 12 months
Oncological Outcomes: Other liver-directed interventions
Time frame: 12 months
Oncological Outcomes: Disease-free and overall survival from time of IRE.
Time frame: 12 months
Quality of life - pre procedure
Time frame: pre procedure up to 7 days
Quality of life - 7 days follow-up
Time frame: 7 days
Quality of life - 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ajith Siriwardena, MD FRCS principal investigator
Manchester Royal Infirmiary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible Electroporation in people with Colorectal Adenocarcinoma Metastatic in the Liver and Liver Ablation, run by Angiodynamics, Inc. at 1 site in United Kingdom.
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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 10 Oct 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitchell Vanderpoll (+44 7790921819, mvanderpoll@angiodynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Tumour Eradication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2025.