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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAdventHealth

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hepatic Artery Infusion Pump (HAIP)

    Device

    HAIP placement for metastatic disease to the liver

  • Floxuridine (FUDR)

    Drug

    FUDR-based chemotherapy

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Hepatic Artery Pump Placement2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival

Time (months) from hepatic artery infusion (HAI) pump placement to disease progression or death, whichever occurs first.

Time frame
From pump placement to disease progression or death, up to 60 months
2

Hepatic Disease Control Rate

Percentage of patients with stable disease, partial response, or complete response based on RECIST criteria.

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

Secondary outcomes

1

Perioperative Complications

Number of participants that experience a perioperative complication such as surgical complications, unplanned returns to the operating room, or readmissions.

Time frame
From pump placement to disease progression or death, up to 60 months
2

Catheter-Related Complications

Number of participants that experience complications related to the HAI pump catheter, such as occlusion, infection, or malfunction.

Time frame
From pump placement to disease progression or death, up to 60 months
3

Overall Survival

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

Time frame
From pump placement to death, up to 60 months

Other outcomes

Sponsors and contacts

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