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

ConditionsColorectal Adenocarcinoma Metastatic in the LiverLiver AblationLiver Cancer, Adult
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAngiodynamics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients involved in other research studies.

Inability to give informed consent.

Patients who are pregnant.

Platelet count < 50x109 U/L.

Trial design

Design model

Single group

Treatments tested in this trial

  • Irreversible Electroporation

    Device

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Use of NanoKnife System for ablation of metastatic colorectal lesionsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Complications of IRE: Episode-related complications:

All complications recorded during inpatient stay recorded using Clavien-Dindo and CCI

Time frame
30 days
2

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

Time frame
12 months
3

Oncological outcomes: Local progression at site of IRE-treated lesion

Local progression at site of IRE-treated lesion

Time frame
12 months
4

Oncological Outcomes: Re-ablation and modality.

Re-ablation and modality.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Angiodynamics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: