Gemcitabine for Pancreatic Cancer
(PRISM-TAMP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Systemic Chemotherapy
Participants receive neoadjuvant systemic chemotherapy with modified FOLFIRINOX
Radiation Therapy
Participants undergo stereotactic body radiation therapy (SBRT)
TAMP Chemotherapy
Gemcitabine is delivered directly to the tumor through the arterial blood supply using the RenovoCath® catheter system
Surgical Resection
Participants who remain appropriate surgical candidates proceed to operative resection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Vermont
Lead Sponsor
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