COLDFIRE-2 study: Colorectal metastatic liver disease: efficacy of irreversible electroporation (IRE) - a phase II clinical trial - COLDFIRE-2: efficacy of IRE for colorectal liver metastases

Vrije Universiteit Medisch Centrum0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Screening must be performed no longer than 4 weeks prior to study inclusion. Subjects are eligible if they meet the following 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 >= 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:
•o Hemoglobin >= 5.6 mmol/L;
•o Absolute neutrophil count (ANC) >= 1,500/mm3;
•o Platelet count >= 100*109/l;
•o Total bilirubin <= 1.5 times the upper limit of normal (ULN);
•o ALT and AST <= 2.5 x ULN
•o Serum creatinine <= 1.5 x ULN or a calculated creatinine clearance * 50 ml/min;
•o Prothrombin time or INR < 1.5 x ULN;
•o 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

•Subjects who meet the following criteria at the time of screening will be excluded:
•Lesion > 3,5 cm size;
•History of epilepsy;
•Extrahepatic metastases rendering local therapy unfeasible;
•History of cardiac disease:
•o Congestive heart failure >NYHA class 2;
•o Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
•o Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker/ICD (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;
•Use of anti-convulsives and anti-arrhythmic drugs other than beta blockers for antiepileptic or antiarrhythmic purpose;
•Allergy to contrast media which cannot be adequately prevented with the standard contrast allergy prevention regimen;
•Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study

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