Pilot-study: Investigation of the safety of irreversible electroporation (IRE) as novel treatment for colorectal liver metastases - a phase I clinical study - Pilot study: Safety of Irreversible Electroporation (IRE) in CRLM

Vrije Universiteit Medisch Centrum0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月29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
•* Liver metastases visible on FDG PET-CT or contrast-enhanced CT, size * 3,5 cm.
•* Resectability (re)confirmed by intraoperative US
•* Age 18 years or older
•* WHO performance status 0 * 2
•* Life expectancy of at least 12 weeks
•* 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 ³ 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.

•Subjects who meet the following criteria at the time of screening will be excluded:
•* Lesion > 3,5 cm
•* 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)
•* History of epilepsy
•* Uncontrolled hypertension. Blood pressure must be *160/95 mmHg at the time of screening without medication or on a stable antihypertensive regimen.
•* Uncontrolled infections (> grade 2 NCI-CTC version 3.0).
•* Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment.
•* Immunotherapy * 6 weeks prior to the procedure
•* Chemotherapy within 12 weeks before surgery
•* Radiotherapy, RFA or MWT treatment of target lesions prior to resection
•* Concomitant use of dexamethasone, anti-convulsants and anti-arrhythmic drugs.
•* Severe allergy for contrast media not controlled with premedication.
•* Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

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