NL-OMON41424招募中2 期
PANFIRE - Pilot-study: Non-thermal ablation using Irreversible Electroporation (IRE) to treat locally advanced pancreatic carcinoma - a phase I clinical study - Pilot-study: Treatment of LAPC with Irreversible Electroporation (IRE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Screening must be performed no longer than 2 weeks prior to study inclusion. Subjects are eligible if they meet the following criteria:;* Histologic or cytologic confirmation of primary pancreatic carcinoma;
- •* Radiologic confirmation of unresectable pancreatic carcinoma without distant metastases by at least ceCT of chest and abdomen, performed maximum 2 weeks prior to the procedure;
- •* Maximum tumor diameter * 5 cm;
- •* Age * 18 years;
- •* ASA-classificaton 0 * 3;
- •* 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 bilirubine * 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;
排除标准
- •Subjects who meet the following criteria at the time of screening will be excluded:
- •* Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
- •* Extrapancreatic metastases;
- •* Successful downstaging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor;
- •* History of epilepsy;
- •* History of cardiac disease:
- •- Congestive heart failure >NYHA class 2;
- •- Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to
- •screening);
- •- Ventricular cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen 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);
- •* 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 * 6 weeks prior to the procedure;
- •* Radiotherapy * 6 weeks prior to the procedure;
- •* Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta blockers for hypertension);
- •* 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
研究者
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