About this trial
The goal of this observational study is to evaluate whether hepatic artery infusion pump (HAIP) chemotherapy can improve outcomes in patients with pancreatic or duodenal adenocarcinoma who have isolated or liver-dominant metastases after surgery and systemic chemotherapy. The main questions it aims to answer are:
Does HAIP chemotherapy improve liver tumor response based on imaging criteria (RECIST)? What are the progression-free survival and overall survival outcomes in this patient population?
Participants will:
Undergo placement of a hepatic artery infusion pump as part of standard clinical care Receive floxuridine (FUDR)-based chemotherapy through the pump Have clinical data, imaging results, and laboratory markers (e.g., ctDNA, CEA, CA 19-9) collected from their medical records over time
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years
Histologically confirmed pancreatic or duodenal adenocarcinoma
Completed or currently receiving curative-intent treatment
Evidence of isolated or liver-dominant metastases (radiographic or clinical)
Disqualifiers
None
Trial population
AdventHealth Orlando
Trial design
Cohort
Prospective
Treatments tested in this trial
Hepatic Artery Infusion Pump (HAIP)
DeviceHAIP placement for metastatic disease to the liver
Floxuridine (FUDR)
DrugFUDR-based chemotherapy
Treatment groups
Trial outcomes
Primary outcomes
Progression-Free Survival
Time (months) from hepatic artery infusion (HAI) pump placement to disease progression or death, whichever occurs first.
Hepatic Disease Control Rate
Percentage of patients with stable disease, partial response, or complete response based on RECIST criteria.
Secondary outcomes
Perioperative Complications
Number of participants that experience a perioperative complication such as surgical complications, unplanned returns to the operating room, or readmissions.
Catheter-Related Complications
Number of participants that experience complications related to the HAI pump catheter, such as occlusion, infection, or malfunction.
Overall Survival
Time (months) from HAI pump placement to death, regardless of cause
Sponsors and contacts
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