COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases

Prior treatment

• Immunotherapy ≤ 2 weeks prior to the procedure;
• Chemotherapy and/or targeted therapy ≤ 2 weeks prior to the procedure;

Other illness

• \>10 CRLM; \>5 CRLM when extra-hepatic disease is present;
• Subjects who have progressive disease after neo-adjuvant systemic therapy;
• History of epilepsy;
• History of cardiac disease:
• Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
• Severe allergy to contrast media not controlled with premedication;
• Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.

Lab values

• Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites);

Other

• Radical treatment unfeasible or unsafe (e.g. insufficient FLR);
• Positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis;
• Pregnant or breast-feeding subjects;

• Histological documentation of primary colorectal tumor is available;
• 1-3 CRLM visible on ceCT and/or MRI, size 0-5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;
• Additional CRLM are allowed if considered either resectable or ablatable with a maximum of 10 CRLM. In patients with extrahepatic disease, a maximum of 5 additional CRLM is allowed;
• No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with some exclusions mentioned in the exclusion criteria);
• Prior focal liver treatment is allowed;
• Subjects should preferably be treated with neo-adjuvant systemic therapy;
• Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment who are unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable);
• Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to definite inclusion;
• ASA classification 0 - 3;
• Age \>18 years;
• Written informed consent;