Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2PRISM-TAMPNCT07477418
PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)
A Phase 1/2 study testing Gemcitabine Delivered by Transarterial Microperfusion in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Borderline Resectable Pancreatic Cancer, run by University of Vermont at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), Borderline Resectable Pancreatic Cancer, Pancreatic Neoplasms
- What is being tested?
- Gemcitabine Delivered by Transarterial Microperfusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- Age ≥ 18 years.
- ECOG performance status of 0 or 1.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
Randall Holcombe, MD, MBA, 1 (802) 656-2021, randall.holcombe@med.uvm.edu
conor O'Neill, MD
About this study
Official title: PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP): A Phase Ib/II Open-Label 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.
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies, with low long-term survival rates despite advances in systemic chemotherapy, radiation therapy, and surgical techniques. Surgical resection offers the only potential for cure; however, many patients present with borderline resectable disease, where tumor involvement of adjacent vascular structures increases the risk of incomplete resection and positive surgical margins. Neoadjuvant treatment strategies are commonly used in this population to improve the likelihood of margin-negative (R0) resection, but local disease progression and incomplete tumor response remain significant challenges.
Trans-arterial microperfusion (TAMP) chemotherapy is a locoregional drug delivery platform designed to enhance intratumoral drug concentration while limiting systemic exposure. Using the RenovoCath® catheter system, chemotherapy is delivered directly into the arterial supply of the pancreas under controlled pressure conditions. Prior early-phase clinical studies of TAMP-delivered gemcitabine in patients with locally advanced PDAC have demonstrated feasibility and acceptable safety profiles, as well as evidence of improved local drug delivery compared with standard intravenous administration. However, the use of TAMP chemotherapy in the neoadjuvant setting for borderline resectable PDAC has not been well studied.
The PRISM-TAMP study is a Phase Ib/II, single-arm, open-label clinical trial designed to evaluate the safety and tolerability of incorporating TAMP-delivered gemcitabine into a modern neoadjuvant treatment regimen for patients with borderline resectable PDAC. In this study, patients receive standard systemic chemotherapy with modified FOLFIRINOX, followed by stereotactic body radiation therapy (SBRT), consistent with contemporary neoadjuvant management approaches. After completion of chemoradiation, patients undergo TAMP delivery of gemcitabine using the RenovoCath® catheter system. Gemcitabine is an FDA-approved chemotherapy agent for pancreatic cancer, and its use in this protocol is on-label; the investigational aspect of the study relates to the method of delivery rather than the drug itself.
Radiation therapy is included as a required component of the treatment sequence based on preclinical and early clinical data suggesting that radiation may favorably modify the tumor microenvironment and enhance retention of intra-arterially delivered gemcitabine. The intent of radiation in this study is not solely cytotoxic, but also to serve as a biological modulator that may improve the effectiveness of subsequent TAMP chemotherapy.
Following completion of neoadjuvant therapy, patients who remain appropriate surgical candidates proceed to operative resection per standard surgical practice. Pathologic assessment of the resected specimen is performed to evaluate tumor regression and margin status. Patients are followed postoperatively for safety outcomes and disease status.
The primary objective of the study is to assess the safety and tolerability of neoadjuvant TAMP-delivered gemcitabine when administered following systemic chemotherapy and SBRT in patients with borderline resectable PDAC. Secondary objectives include evaluation of intraoperative surgical margin status and pathologic tumor regression. Exploratory objectives include assessment of relapse-free survival. This study is intended to generate safety and feasibility data to inform future studies evaluating locoregional chemotherapy strategies in pancreatic cancer.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Borderline Resectable Pancreatic Cancer, Pancreatic Neoplasms
- Being tested
- Gemcitabine Delivered by Transarterial Microperfusion
- Keywords
- Neoadjuvant Therapy, Gemcitabine, Intra-arterial Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine Delivered by Transarterial MicroperfusionCombination 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 group | Role | What they receive |
|---|---|---|
| Neoadjuvant TAMP Gemcitabine | Experimental | 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. Receives: Combination Product: Gemcitabine Delivered by Transarterial Microperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery
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.
Measured: 3 years
Secondary outcomes (4)
Surgical Margin Status
Surgical margin status will be assessed on the resected surgical specimen following completion of neoadjuvant therapy. Margin status will be categorized based on pathologic evaluation as margin-negative (R0) or margin-positive (R1 or R2) according to standard institutional pathology criteria.
Measured: At the time of surgical resection
Pathologic Tumor Regression
Pathologic tumor regression will be assessed on the surgical resection specimen following completion of neoadjuvant therapy. Tumor response will be evaluated by a pathologist using a standardized tumor regression grading system to characterize the extent of residual viable tumor relative to treatment-related changes.
Measured: At the time of surgical resection
Pancreatic Duct Size
Intraoperative pancreatic duct size.
Measured: At the time of surgical resection
Maintenance of Chemotherapy Relative Dose Intensity
The proportion of participants who maintain a relative dose intensity of at least 80% during neoadjuvant modified FOLFIRINOX chemotherapy will be assessed based on delivered doses relative to planned doses over the chemotherapy treatment period.
Measured: From start of chemotherapy to surgery resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor O'Neill, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477418
- Sponsor's protocol ID
- STUDY00004018/UVMCC2509
- Acronym
- PRISM-TAMP
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP): A Phase Ib/II Open-Label Trial
- ClinicalTrials.gov ID
- NCT07477418
- Acronym / sponsor ID
- PRISM-TAMP / STUDY00004018/UVMCC2509
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Borderline Resectable Pancreatic Cancer, Pancreatic Neoplasms
- Keywords
- Neoadjuvant Therapy, Gemcitabine, Intra-arterial Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies, with low long-term survival rates despite advances in systemic chemotherapy, radiation therapy, and surgical techniques. Surgical resection offers the only potential for cure; however, many patients present with borderline resectable disease, where tumor involvement of adjacent vascular structures increases the risk of incomplete resection and positive surgical margins. Neoadjuvant treatment strategies are commonly used in this population to improve the likelihood of margin-negative (R0) resection, but local disease progression and incomplete tumor response remain significant challenges.
Trans-arterial microperfusion (TAMP) chemotherapy is a locoregional drug delivery platform designed to enhance intratumoral drug concentration while limiting systemic exposure. Using the RenovoCath® catheter system, chemotherapy is delivered directly into the arterial supply of the pancreas under controlled pressure conditions. Prior early-phase clinical studies of TAMP-delivered gemcitabine in patients with locally advanced PDAC have demonstrated feasibility and acceptable safety profiles, as well as evidence of improved local drug delivery compared with standard intravenous administration. However, the use of TAMP chemotherapy in the neoadjuvant setting for borderline resectable PDAC has not been well studied.
The PRISM-TAMP study is a Phase Ib/II, single-arm, open-label clinical trial designed to evaluate the safety and tolerability of incorporating TAMP-delivered gemcitabine into a modern neoadjuvant treatment regimen for patients with borderline resectable PDAC. In this study, patients receive standard systemic chemotherapy with modified FOLFIRINOX, followed by stereotactic body radiation therapy (SBRT), consistent with contemporary neoadjuvant management approaches. After completion of chemoradiation, patients undergo TAMP delivery of gemcitabine using the RenovoCath® catheter system. Gemcitabine is an FDA-approved chemotherapy agent for pancreatic cancer, and its use in this protocol is on-label; the investigational aspect of the study relates to the method of delivery rather than the drug itself.
Radiation therapy is included as a required component of the treatment sequence based on preclinical and early clinical data suggesting that radiation may favorably modify the tumor microenvironment and enhance retention of intra-arterially delivered gemcitabine. The intent of radiation in this study is not solely cytotoxic, but also to serve as a biological modulator that may improve the effectiveness of subsequent TAMP chemotherapy.
Following completion of neoadjuvant therapy, patients who remain appropriate surgical candidates proceed to operative resection per standard surgical practice. Pathologic assessment of the resected specimen is performed to evaluate tumor regression and margin status. Patients are followed postoperatively for safety outcomes and disease status.
The primary objective of the study is to assess the safety and tolerability of neoadjuvant TAMP-delivered gemcitabine when administered following systemic chemotherapy and SBRT in patients with borderline resectable PDAC. Secondary objectives include evaluation of intraoperative surgical margin status and pathologic tumor regression. Exploratory objectives include assessment of relapse-free survival. This study is intended to generate safety and feasibility data to inform future studies evaluating locoregional chemotherapy strategies in pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant TAMP Gemcitabine | Experimental | Combination Product: Gemcitabine Delivered by Transarterial MicroperfusionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Borderline resectable disease as defined by the ABC classification criteria, incorporating one or more of the following:
- No prior treatment for PDAC (e.g., chemotherapy, radiation, or surgery).
- Age ≥ 18 years.
- ECOG performance status of 0 or 1.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine Delivered by Transarterial MicroperfusionGemcitabine 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. | Combination product | Neoadjuvant TAMP Gemcitabine |
Primary outcome
Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery
Time frame: 3 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.
4 secondary outcomes
Surgical Margin Status
Time frame: At the time of surgical resection
Pathologic Tumor Regression
Time frame: At the time of surgical resection
Pancreatic Duct Size
Time frame: At the time of surgical resection
Maintenance of Chemotherapy Relative Dose Intensity
Time frame: From start of chemotherapy to surgery resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Related trials for Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
RecruitingPhase 3
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine Delivered by Transarterial Microperfusion in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Borderline Resectable Pancreatic Cancer, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Conor O'Neill, MD (1 (802) 656-2021, conor.oneill@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.