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PRISM-TAMP Study for Pancreatic Cancer

This study, called PRISM-TAMP, is for people with pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer that is considered "borderline resectable." This means the tumor is close to important blood vessels, making surgery challenging. The study is testing a new way to deliver chemotherapy called transarterial microperfusion (TAMP) using the drug gemcitabine. This method delivers the chemotherapy directly to the tumor through an artery, aiming to increase the drug's concentration where it's needed most. You would first receive standard chemotherapy (modified FOLFIRINOX) and radiation therapy (stereotactic body radiation therapy). Researchers want to see how safe and practical it is to add TAMP-delivered gemcitabine to this standard treatment. The study plans to enroll 10 participants and will track safety and side effects for three years.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It is an early-phase study (Phase Ib/II) and plans to enroll 10 participants.
What's involved
Participants will receive standard systemic chemotherapy with modified FOLFIRINOX, followed by stereotactic body radiation therapy, and then transarterial microperfusion (TAMP) delivery of gemcitabine.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for three years to assess the safety and tolerability of the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07477418

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Vermont
~10 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Gemcitabine Delivered by Transarterial Microperfusion

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery
Measured over 3 years

Conditions

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

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Pancreatic Ductal Adenocarcinoma

NCT07477418

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Vermont Medical Center

    Burlington, Vermontstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Conor O'Neill, MD
[email protected]
1 (802) 656-2021
Email the study team

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Eligibility criteria

Inclusion

Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).
Borderline resectable disease as defined by the ABC classification criteria, incorporating one or more of the following:
Anatomy (A): Vascular involvement consistent with borderline resectable or resectable locally advanced-PDAC (e.g., abutment of the superior mesenteric vein or artery, portal vein, or celiac axis) as determined by cross-sectional imaging
Biology (B): Concern for extra-pancreatic metastasis or known N1 disease or suspicious but nonconfirmatory liver/lung lesion(s). CA19-9\>500 after normalized bilirubin
Condition (C): Functional status and comorbidity profile adequate for curative-intent surgery, as assessed by the multidisciplinary team, specifically WHO PS \>/=1.
No prior treatment for PDAC (e.g., chemotherapy, radiation, or surgery).
Age ≥ 18 years.
ECOG performance status of 0 or 1.
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Locally Advanced PDAC or metastatic PDAC
Histology other than adenocarcinoma
Non-accessible arterial anatomy
Gemcitabine hypersensitivity or contraindication to mFOLFIRINOX therapy based on provider assessment

What this trial measures

  • Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery3 years

    Safety and tolerability will be assessed by the incidence, severity, and relationship of adverse events associated with transarterial microperfusion delivery of gemcitabine. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.