Trial summary: This study is evaluating the effectiveness of a procedure called irreversible electroporation, which uses electrical pulses to destroy cancer cells, in people with stage III pancreatic cancer who have received 3 months of chemotherapy.
Status: OPEN - Recruiting
Trial identifier: ACTRN12621000955819
Sponsor: The Walter and Eliza Hall Institute
Phase: I
Diagnosis: Locally advanced (Stage III) unresectable pancreatic ductal adenocarcinoma
Line of therapy: First-line
Treatment: Irreversible Electroporation (IRE) with the NanoKnife system (surgical)
  • Key inclusion criteria
    1. Patient has a diagnosis of unresectable Stage 3 pancreatic ductal adenocarcinoma cancer cytologically or pathologically confirmed as per American Joint Committee on Cancer (AJCC) staging criteria.
    2. Patient is newly diagnosed and has only received a single line of therapy for at least 3 months prior to enrolment. They must have received either modified FOLFIRINOX or gemcitabine-based chemotherapy.
    3. Patient has a tumour evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
    4. Maximum axial tumour dimension of less than or equal to 3.5 cm, after receiving at least three months of treatment with a modified FOLFIRINOX or gemcitabine-based regimen.
    5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    6. Patient has an American Society of Anaesthesiologists (ASA) classification of physical health status of 1 or 2.
  • Key exclusion criteria
    1. Patients who at 3 months after induction chemotherapy have evidence of disease progression.
    2. Patients who have undergone prior radiation therapy or surgical resection for treatment of pancreatic cancer.
    3. Patients who have received IRE for margin accentuation.
    4. Patients who are unable to tolerate general anaesthetic with full skeletal muscle blockade.
    5. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in-situ.
    6. Patients who are actively bleeding, anticoagulated, coagulopathy, or have any of the following haematology results:
      • Haemoglobin <100 g/L without the support of growth factors or transfusion
      • Absolute neutrophil count <1.5 x 109/L
      • Platelet count <100 x 109/L
    7. Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.
    8. Patients with history of epilepsy or other neurological disease.
    9. Patients with inadequate organ function:
      • Stage 3 (GFR 30 to 44ml/min), 4 (15 to 29ml/min), or 5 (<15ml/min) chronic kidney disease.
      • Aspartate aminotransferase/alanine aminotransferase >2.5 x upper limit of normal.
      • Clinically significant cardiovascular disease, i.e. active or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmias requiring medications, uncontrolled hypertension.
    10. Patients who are pregnant or breastfeeding. Women of childbearing potential (WOCBP) must undergo pregnancy testing.

DIRECT-InspIRE Australia

Locations: Epworth Freemasons (East Melbourne).

Epworth PI: Mr Brett Knowles

Jreissati Pancreatic Centre at Epworth 

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Please contact us for more information on 03 9426 8880 or email [email protected]


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