PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT07477418
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Borderline Resectable Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine Delivered by Transarterial Microperfusion — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant TAMP Gemcitabine
    Participants in this single-arm study receive neoadjuvant systemic chemotherapy with modified FOLFIRINOX followed by stereotactic body radiation therapy (SBRT), consistent with standard-of-care management for borderline resectable pancreatic ductal adenocarcinoma. After completion of chemoradiation, participants undergo trans-arterial microperfusion (TAMP) delivery of gemcitabine using the RenovoCath® catheter system. Following neoadjuvant therapy, participants who remain appropriate surgical candidates proceed to surgical resection per standard clinical practice.

Primary Outcome Measure

Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401
Randall Holcombe, MD, MBA
[email protected]
1 (802) 656-2021
conor O'Neill, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Vermont Medical Center· Burlington, VT

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