Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma

Detailed Study Description This study is a single-center, prospective observational feasibility study designed to evaluate the clinical outcomes of hepatic artery infusion pump (HAIP) chemotherapy in patients with pancreatic or duodenal adenocarcinoma who develop isolated or liver-dominant metastases following primary tumor resection and systemic chemotherapy. The study is conducted at AdventHealth Orlando and will enroll approximately 10 adult patients who meet predefined clinical eligibility criteria.

Study Rationale Pancreatic and duodenal adenocarcinomas have a poor prognosis when metastatic, particularly when the liver is involved. While systemic chemotherapy remains the standard of care, outcomes are limited. Regional therapies such as HAIP chemotherapy offer a biologically plausible strategy by delivering high concentrations of chemotherapy directly to liver metastases via the hepatic arterial supply, potentially improving tumor response while limiting systemic toxicity. However, evidence supporting this approach in pancreatic and duodenal cancers remains limited, and its use is considered investigational.

Objectives The primary objective is to assess liver-specific tumor response to HAIP chemotherapy using floxuridine (FUDR), measured by RECIST 1.1 criteria. Secondary objectives include evaluating progression-free survival (PFS), overall survival (OS), changes in biochemical tumor markers (ctDNA, CEA, CA 19-9), and the incidence of perioperative, catheter-related, and chemotherapy-associated complications.

Study Design and Population This is a non-randomized, single-arm observational study. Eligible participants are adults aged 18-80 years with histologically confirmed pancreatic or duodenal adenocarcinoma who have undergone or are undergoing curative-intent treatment and have evidence of isolated or liver-dominant metastatic disease. All participants must be deemed appropriate candidates for HAIP placement and chemotherapy by a multidisciplinary oncology team.

Intervention and Clinical Care Participants will receive HAIP placement and FUDR-based chemotherapy as part of their standard clinical treatment. The study does not introduce any experimental interventions; rather, it systematically captures and analyzes data generated during routine care. All treatment decisions, including timing and regimen, are determined by the treating oncology team independent of study participation.

Data Collection and Follow-up No additional study-specific visits or procedures are required. Clinical data-including imaging results, laboratory values, treatment details, and outcomes-will be extracted from the electronic medical record (EMR). Participants will be followed for up to 5 years after HAIP placement to assess long-term outcomes.

Outcomes Primary outcomes include progression-free survival and hepatic disease control rate. Secondary outcomes include overall survival, treatment-related toxicities, perioperative and catheter-related complications, and trends in tumor biomarkers. Descriptive statistics and Kaplan-Meier survival analyses will be used due to the small sample size and feasibility nature of the study.

Risks and Benefits Because this is an observational study, there are no additional risks beyond those associated with standard clinical care. The primary risk relates to potential loss of confidentiality, which will be mitigated through data de-identification and secure storage. While participants may not directly benefit from study participation, the findings may inform future treatment strategies and improve patient selection for regional therapies.

Significance This study aims to generate preliminary data on the safety, feasibility, and potential efficacy of HAIP chemotherapy in a highly selected patient population. The results may support future larger studies and contribute to the development of more effective treatment approaches for patients with liver-dominant metastatic pancreatic and duodenal cancers.