Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
Public ClinicalTrials.gov record NCT05634720. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy. Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes. The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and overall survival (OS).
Study identification
- NCT ID
- NCT05634720
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2024
- Primary completion
- Nov 17, 2025
- Completion
- Dec 30, 2028
- Last update posted
- Jan 25, 2026
2024 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05634720, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 25, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05634720 live on ClinicalTrials.gov.