An observational study in Pancreas Cancer With Hepatic Metastase, Pancreas Adenocarcinoma and Duodenal Cancer, sponsored by AdventHealth. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by AdventHealth · Observational
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Among 13 studies in Duodenal Neoplasms with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Duodenal Neoplasms · United States.
Among the 13 studies in Duodenal Neoplasms with a site in United States, this one is one of 2 that started in 2026, is one of 4 observational ones, and was the 13th registered.
51 studies on the registry are indexed under Duodenal Neoplasms; 14 are open to participants now.
Browse Duodenal Neoplasms studies →4 of the 13 studies in Duodenal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Masonic Cancer Center, University of Minnesota · Sites in United States
Ages 18+
University of Nebraska · Sites in United States
Ages 19–110 · Healthy volunteers
University of Illinois at Chicago · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Duodenal Neoplasms studies recruiting now, 6 (55%) set no upper age limit and 1 (9%) stops at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 200 across 17 observational studies indexed under Duodenal Neoplasms.
Median enrollment 50 across the 9 interventional studies, 6,100 across the 4 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 13 has an industry lead sponsor. The 10 most frequent:
AdventHealth is the lead sponsor of 114 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
AdventHealth has 1 study filed under Duodenal Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies in Duodenal Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06411795Masonic Cancer Center, University of MinnesotaRectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy | 2027-01-01 |
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Among the 13 studies in Duodenal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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.
AdventHealth Orlando
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Patients who are clinically ineligible for HAIP placement or FUDR therapy are excluded
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Hepatic Artery Infusion Pump (HAIP) · Drug: Floxuridine (FUDR)
HAIP placement for metastatic disease to the liver
FUDR-based chemotherapy
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
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
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
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
Overall Survival
Time (months) from HAI pump placement to death, regardless of cause
Time frame: From pump placement to death, up to 60 months
Plan to share: No
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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