Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer

This is an interventional treatment trial for Pancreatic Cancer Read More

Inclusion Criteria:

• Radiologic confirmation of unresectable pancreatic cancer by at least CT of chest and abdomen
• Screening must be performed no longer than 2 weeks prior to study inclusion
• 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;

Exclusion Criteria:

• Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
• Successful down staging 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);
  • 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. 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.