International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE

Not Applicable

Not yet recruiting

• Conditions: Colorectal Adenocarcinoma Metastatic in the Liver; Liver Ablation; Liver Cancer, Adult

• Registration Number: NCT07191548
• Lead Sponsor: Angiodynamics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Study First Posted: 2025-09-25
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-08
• Last Update Posted: 2025-10-10
• Study Start: 2026-02-01
• Primary Completion: 2028-02
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.
• 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

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Target Tumour Eradication	6 months	The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria.

Secondary Outcome Measures

Name	Time	Method
Complications of IRE: Episode-related complications:	30 days	All complications recorded during inpatient stay recorded using Clavien-Dindo and CCI
Complications of IRE: Intervention for local liver-related complications of IRE	12 months	Intervention for local liver-related complications of IRE within 12 months of the procedure categorised as radiological, surgical or medical
Oncological Outcomes: Other liver-directed interventions	12 months	Any further liver-directed, anti-cancer intervention including surgery and radiotherapy.
Quality of life - pre procedure	pre procedure up to 7 days	EQ-5D-5L survey
Oncological outcomes: Local progression at site of IRE-treated lesion	12 months	Local progression at site of IRE-treated lesion
Oncological Outcomes: Re-ablation and modality.	12 months	Re-ablation and modality.
Oncological Outcomes: Post IRE Chemotherapy	12 months	Any use of chemotherapy after IRE
Oncological Outcomes: New lesions	12 months	Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up.
Oncological Outcomes: Disease-free and overall survival from time of IRE.	12 months	Disease-free and overall survival from time of IRE.
Quality of life - 7 days follow-up	7 days	EQ-5D-5L survey
Quality of life - 6 months	6 months	EQ-5D-5L survey

Trial Locations

Locations (1)

Manchester Royal Infirmiary; 🇬🇧 Manchester, United Kingdom