Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases (COLDFIRE-2)

This is an interventional treatment trial for Colorectal Liver Metastases focused on measuring Colorectal liver metastases (CRLM), Tumor ablation, Irreversible electroporation (IRE), Interventional oncology, NanoKnife, Colorectal liver metastasis, unresectable and not-thermally ablative due to location near vulnerable structures like vessels or bile ducts Read More

Inclusion Criteria:

• Histological or cytological documentation of primary colorectal tumor;
• Previous induction chemotherapy due to unresectability; no intra- or extrahepatic disease progression under induction chemotherapy; OR
• Previous chemotherapy for other CRLM, now presenting with renewed CRLM unsuitable for resection or thermal ablation;
• Liver metastases F-18-FDG PET avid and visible on ceCT, size ≤ 3,5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;
• Age more than 18 years;
• ASA classification 0 - 3;

• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion:

  • Hemoglobin ≥ 5.6 mmol/L;
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3;
  • Platelet count ≥ 100*109/l;
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
  • ALT and AST ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance > 50 ml/min;
  • Prothrombin time or INR < 1.5 x ULN;
  • Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician)
• Written informed consent

Exclusion Criteria:

• Lesion > 3,5 cm size;
• History of epilepsy;
• Extrahepatic metastases rendering local therapy unfeasible;

• History of cardiac disease:

  • Congestive heart failure >NYHA class 2;
  • Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
  • Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted);
• Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
• Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites);
• Pregnant or breast-feeding subjects;
• Immunotherapy ≤ 6 weeks prior to the procedure;
• Chemotherapy ≤ 6 weeks prior to the procedure;
• Concomitant use of anti-convulsives and anti-arrhythmic drugs other than beta blockers for antiepileptic or antiarrhythmic purpose;
• Allergy to contrast media;
• Any implanted stimulation device;
• Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study