Clinical trial · Interventional
PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)
PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP): A Phase Ib/II Open-Label Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Borderline Resectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine Delivered by Transarterial Microperfusion | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant TAMP Gemcitabine
- description
- 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.
- interventionNames
- Combination Product: Gemcitabine Delivered by Transarterial Microperfusion
Primary outcomes (1)
- measure
- Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available