Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
Status:
Not yet recruiting
Trial end date:
2028-06-30
Target enrollment:
Participant gender:
Summary
This is a window-of-opportunity study which will evaluate the safety and feasibility of
single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with
localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and
systemic chemotherapy.
Current standard-of-care therapy for patients with localized PDAC includes surgical resection
and six months of systemic chemotherapy. Because the sequence of these treatments (surgery
and chemotherapy) is not well established, we will include both patients planned to undergo
surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy
before surgery. This will allow us to test the safety and feasibility of adding single-dose
neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies
employed in typical clinical practice. Moreover, the window-of-opportunity design is intended
to make sure that all patients receive HA chemotherapy in addition to standard-of-care
surgery and systemic chemotherapy, so as not to withhold the treatment approach currently
associated with best outcomes.
The primary endpoint is safety and feasibility, and patients will be followed for 30 days
after resection of their primary tumors to assess these outcomes. Following the short-term
follow-up period, patients move to long-term follow-up, which will occur every three months
after resection of the primary tumor, for a period of up to three years. Long-term secondary
endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and
overall survival (OS).