Recruiting

HAIP with FUDR

Sponsor:

AdventHealth

Code:

NCT07845617

Conditions

Pancreas Cancer With Hepatic Metastase

Pancreas Adenocarcinoma

Duodenal Cancer

Duodenal Adenocarcinoma

Ampullary Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hepatic Artery Infusion Pump (HAIP)

Floxuridine (FUDR)

Study Details

Brief summary:

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

Conditions

Pancreas Cancer With Hepatic Metastase

Pancreas Adenocarcinoma

Duodenal Cancer

Duodenal Adenocarcinoma

Ampullary Adenocarcinoma

Study ID

NCT07845617

Start date

Nov 1, 2026

Status verified date

Jul, 2026

Completion date

May 2, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Hepatic Artery Pump Placement

Interventions

Hepatic Artery Infusion Pump (HAIP)

HAIP placement for metastatic disease to the liver

Floxuridine (FUDR)

FUDR-based chemotherapy

Primary outcome measure

  • Progression-Free Survival [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Maggie Polanco, RN

407-303-7381maggie.polanco@adventhealth.com

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32804

Contacts

Maggie Polanco, RN

maggie.polanco@adventhealth.com

Principal Investigator:

Sebastian de la Fuente, MD

More Information

Sponsor

AdventHealth

Last update posted

Sep 29, 2026

Last verified

Jul, 2026

Keywords

  • Pancreas cancer
  • Pancreas adenocarcinoma
  • Duodenal cancer
  • Liver metastases
  • Ampullary cancer
  • Ampullary adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.