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NCT07477418 · ClinicalTrials.gov registry record · Phase 1
PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)
A Phase 1 study, sponsored by University of Vermont.
- Not yet
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT07477418 is a Phase 1 study that has not yet begun recruiting, run by University of Vermont. The registered enrollment target is 10 participants.
The verdict
NCT07477418, a Phase 1 study, has not yet begun recruiting, sponsored by University of Vermont.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with poor survival outcomes, even when treated with modern chemotherapy and radiation. Patients with borderline resectable PDAC often receive neoadjuvant systemic therapy to improve the likelihood of successful surgical removal of the tumor, but rates of incomplete tumor regression and positive surgical margins remain high. This Phase Ib/II, single-arm study evaluates the safety and feasibility of adding trans-arterial microperfusion (TAMP) delivery of gemcitabine to standard neoadjuvant therapy for patients with borderline resectable PDAC. In this study, patients receive standard systemic chemotherapy with modified FOLFIRINOX followed by stereotactic body radiation therapy (SBRT). After completion of chemoradiation, gemcitabine is delivered directly to the tumor through the arterial blood supply using the RenovoCath® catheter system. Gemcitabine is an FDA-approved chemotherapy drug for pancreatic cancer, and the study is evaluating a novel method of delivering the drug rather than a new medication. The primary objective of the study is to assess the safety and tolerability of neoadjuvant TAMP-delivered gemcitabine in this treatment setting. Secondary objectives include evaluation of surgical margin status and pathologic tumor regression following surgical resection. Exploratory analyses will examine relapse-free survival. Results from this study will help determine whether this locoregional chemotherapy approach can be safely integrated into neoadjuvant treatment strategies for patients with borderline resectable PDAC.
Interventions
- COMBINATION_PRODUCT Gemcitabine Delivered by Transarterial Microperfusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-12 |
| Est. Completion | 2031-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07477418
The ClinicalTrials.gov registry entry for NCT07477418 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gemcitabine Delivered by Transarterial Microperfusion is the first listed.
NCT07477418 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07477418 about?
NCT07477418 is a clinical study titled "PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)". Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with poor survival outcomes, even when treated with modern chemotherapy and radiation. Patients with borderline resectable PDAC often receive neoadjuvant systemic therapy to improve the likelihood of successful surgical removal of the t...
What is the current status of trial NCT07477418?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-12. Estimated completion is 2031-12.
What interventions are being tested in trial NCT07477418?
The interventions under investigation include: Gemcitabine Delivered by Transarterial Microperfusion (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07477418?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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