HPB1 - A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases
Saturday, February 15, 2020
7:30 AM – 7:45 AM
Location: Sebastian I 1/2
Background: Liver metastases from pancreatic cancer remain highly lethal as median survival remains less than one year with best available systemic chemotherapy. Despite this, response rates have improved with multi-drug regimens and select patients may benefit from liver-directed therapy. Design: A single-arm phase II trial has been designed and opened for accrual. Patients with synchronous pancreatic cancer liver metastasis are eligible. Key eligibility criteria include stable disease after a minimum of 2 months of systemic chemotherapy, elevated CA19-9 at diagnosis, accessibility of the gastroduodenal artery, and age 75 years or younger. Key exclusion criteria include prior primary tumor resection, greater than 60% liver parenchymal involvement, and peritoneal metastasis. After demonstrating stable disease after an initial trial of systemic chemotherapy, enrolled subjects undergo diagnostic laparoscopy to confirm absence of peritoneal metastasis. If eligible to continue, laparotomy is performed with placement of a hepatic arterial infusion (HAI) pump. The primary tumor is treated by resection if distal or irreversible electroporation if proximal. Subjects are then treated with HAI floxuridine in 28-day cycles and concurrent systemic chemotherapy as tolerated. The primary outcome measure is 1-year hepatic progression-free survival (PFS). Secondary outcomes include overall survival, PFS (all sites), rate of hepatic response, and quality of life. This pilot study is seeking a 1-year hepatic PFS of 40% with a sample size of 15 patients. Three patients have been enrolled to date.