PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Safety (number of adverse events)
研究概览
简要总结
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.
The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response.
Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker.
We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening must be performed no longer than 2 weeks prior to study inclusion.
- •Radiologic confirmation of LAPC by at least ceCT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 2 weeks prior to the procedure;
- •Maximum tumor diameter ≤ 5 cm;
- •Histological or cytological confirmation of pancreatic adenocarcinoma;
- •Age ≥ 18 years;
- •ASA-classification 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 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;
排除标准
- •Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
- •Extrapancreatic metastases;
- •Successful down staging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor;
- •Stage IV pancreatic carcinoma;
- •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);
- •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 used for antihypertensive);
- •Allergy to contrast media;
- •Any implanted stimulation device;
- •Any implanted metal stent/device within the area of ablation that cannot be removed;
- •Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;
- •Of note, patients with contra-indications for MRI will not be excluded from participation: in this case radiologic follow-up will consist of CT-scanning according to protocol.
结局指标
主要结局
Safety (number of adverse events)
时间窗: early: 90 days; late: 12 months
Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.
次要结局
- Tumor response(12 months)
研究者
Dr. M.R. Meijerink
Dr.
Amsterdam UMC, location VUmc