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

NCT07845617 | Recruiting FDA Device

• 1 other identifier: 2368506
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreas cancer; Pancreas adenocarcinoma; Duodenal cancer; Liver metastases; Ampullary cancer; Ampullary adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival

  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

  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 Outcomes (3)

• Perioperative Complications

  From pump placement to disease progression or death, up to 60 months

• Catheter-Related Complications

  From pump placement to disease progression or death, up to 60 months

• Overall Survival

  From pump placement to death, up to 60 months

Study Arms (1)

Hepatic Artery Pump Placement

Device: Hepatic Artery Infusion Pump (HAIP); Drug: Floxuridine (FUDR)

Interventions

Hepatic Artery Infusion Pump (HAIP) DEVICE

HAIP placement for metastatic disease to the liver

Hepatic Artery Pump Placement

Floxuridine (FUDR) DRUG

FUDR-based chemotherapy

Hepatic Artery Pump Placement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AdventHealth Orlando

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32804, United States

RECRUITING

Related Publications (4)

• Hashimoto A, Nishiofuku H, Tanaka T, Sho M, Anai H, Nakajima Y, Kichikawa K. Safety and optimal management of hepatic arterial infusion chemotherapy after pancreatectomy for pancreatobiliary cancer. AJR Am J Roentgenol. 2012 Apr;198(4):923-30. doi: 10.2214/AJR.11.6751.

  PMID: 22451562 BACKGROUND

• Kato Y, Tsuyuki A, Kikuchi K, Tokuyama J, Kurihara N, Kumamoto Y, Fujishiro Y, Ebinuma H. Continuous hepatic arterial infusion chemotherapy for liver metastasis from biliary tract and pancreatic cancers. Anticancer Res. 2005 Jan-Feb;25(1B):477-82.

  PMID: 15816615 BACKGROUND

• Endo S, Kawaguchi S, Terada S, Shirane N. Hepatic Arterial Infusion Chemotherapy for Liver Metastases Following Standard Chemotherapy for Pancreatic Cancer. Intern Med. 2021 Jan 15;60(2):223-229. doi: 10.2169/internalmedicine.5449-20. Epub 2020 Sep 19.

  PMID: 32963157 BACKGROUND

• Kemeny N, Huang Y, Cohen AM, Shi W, Conti JA, Brennan MF, Bertino JR, Turnbull AD, Sullivan D, Stockman J, Blumgart LH, Fong Y. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med. 1999 Dec 30;341(27):2039-48. doi: 10.1056/NEJM199912303412702.

  PMID: 10615075 BACKGROUND

MeSH Terms

Conditions

Duodenal Neoplasms; Pancreatic Neoplasms

Interventions

Floxuridine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Maggie Polanco, RN

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 2, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)