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PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)
Sponsor: University of Vermont
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.
Official title: PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP): A Phase Ib/II Open-Label Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-12
Completion Date
2031-12
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Gemcitabine Delivered by Transarterial Microperfusion
Gemcitabine is administered via transarterial microperfusion using an arterial infusion catheter system to deliver chemotherapy directly to the pancreatic tumor bed. Following completion of neoadjuvant systemic chemotherapy with modified FOLFIRINOX and stereotactic body radiation therapy, gemcitabine is infused intra-arterially at a dose of 1000 mg/m² under controlled pressure conditions. The intervention evaluates the safety and feasibility of this locoregional drug delivery approach in the neoadjuvant setting.
Locations (1)
University of Vermont Medical Center
Burlington, Vermont, United States