Brief Summary
The aim of this study is to investigate whether addition of a new therapy using the NanoKnife system improves survival in patients with unresectable stage 3 pancreatic cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs. The Nanoknife system is a type of irreversible electroporation (IRE) device. “Electroporation” is a cellular destruction technology that can be used to treat cancer. It uses electrical pulses to make small holes in cellsthe basic structural and functional unit of all living things that cause cell death. This destroys the targeted tissuea group of cells that work together to perform a function in the body and the treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death.
Intervention/Treatment
- Irreversible Electroporation (IRE)
Inclusion Criteria
- Patient has a diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of unresectable Stage 3 pancreatic ductal adenocarcinomacancer arising from mucus-producing glands in organs cancer cytologically or pathologically confirmed as per American Joint Committee on Cancer (AJCC) stagingthe process of determining how big the cancer is, where it started and if it has spread to other areas criteria.
- 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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells.
- Patient has a tumoura tissue mass that forms from groups of unhealthy cells evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imagingtests that create detailed images of areas inside the body or exploratory surgerya surgical procedure used for conditions that cannot be confirmed by scans and tests alone.
- Maximum axial tumour dimension of less than or equal to 3.5cm, after receiving at least three months of treatment with a modified FOLFIRINOX or gemcitabine-based regimen.
- Patient has an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1.
- Patient has an American Society of Anaesthesiologists (ASA) classification of physical health status of 1 or 2.