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

September 25, 2026 updated by: AdventHealth

Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma: A Prospective Feasibility Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

AdventHealth Orlando

Description

Inclusion Criteria:

  • 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)
  • Deemed clinically eligible for hepatic artery infusion pump (HAIP) placement and floxuridine (FUDR)-based chemotherapy by a multidisciplinary oncology team
  • Scheduled for HAIP placement at AdventHealth Orlando

Exclusion Criteria:

- Patients who are clinically ineligible for HAIP placement or FUDR therapy are excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatic Artery Pump Placement
Device: Hepatic Artery Infusion Pump (HAIP)

HAIP placement for metastatic disease to the liver

Drug: Floxuridine (FUDR)

FUDR-based chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: From pump placement to disease progression or death, up to 60 months

Time (months) from hepatic artery infusion (HAI) pump placement to disease progression or death, whichever occurs first.
From pump placement to disease progression or death, up to 60 months
Hepatic Disease Control Rate
Time Frame: From pump placement to disease progression or death, up to 60 months

Percentage of patients with stable disease, partial response, or complete response based on RECIST criteria.
From pump placement to disease progression or death, up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Complications
Time Frame: From pump placement to disease progression or death, up to 60 months

Number of participants that experience a perioperative complication such as surgical complications, unplanned returns to the operating room, or readmissions.
From pump placement to disease progression or death, up to 60 months
Catheter-Related Complications
Time Frame: From pump placement to disease progression or death, up to 60 months

Number of participants that experience complications related to the HAI pump catheter, such as occlusion, infection, or malfunction.
From pump placement to disease progression or death, up to 60 months
Overall Survival
Time Frame: From pump placement to death, up to 60 months

Time (months) from HAI pump placement to death, regardless of cause
From pump placement to death, up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 2, 2028

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 25, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

September 29, 2026

Last Update Submitted That Met QC Criteria

September 25, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2368506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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