Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer: The SMART Study

What this Trial Is About

Pancreatic cancer is a leading cause of cancer-related death, with many patients presenting with locally advanced disease that cannot be removed by surgery. Researchers are investigating whether adding a new local treatment called irreversible electroporation (IRE) to standard combination chemotherapy can improve survival and disease control for patients with locally advanced pancreatic cancer. This study aims to validate the safety and effectiveness of IRE in real-world patients and compare outcomes to chemotherapy alone. Participants eligible for the study will receive 12 weeks of induction chemotherapy using standard regimens such as FOLFIRINOX or gemcitabine plus nab-paclitaxel. After imaging to assess disease progression, those who respond without progression and meet size criteria will undergo IRE treatment using the NanoKnife device, which uses electrical pulses to destroy tumor cells without harming nearby blood vessels or ducts. Following IRE, patients will be recommended to receive an additional 12 weeks of chemotherapy. Patients not eligible for IRE due to tumor size or other factors will continue chemotherapy alone until progression or eligibility changes. Throughout the study, patients will have regular imaging scans to monitor their cancer every 2 to 3 months, and quality of life will be assessed every three months. Blood samples will be collected at multiple time points for future research on biomarkers. Safety and complications related to IRE will be recorded, and survival outcomes such as progression-free survival at 12 months and overall survival at 24 months will be measured. Patients will remain under follow-up at the cancer center for ongoing monitoring until death or study conclusion.

Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer