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.
Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).
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.
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
Single group
Gemcitabine Delivered by Transarterial Microperfusion
Combination productGemcitabine 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.
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.
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.
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.
Pancreatic Duct Size
Intraoperative pancreatic duct size.
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.
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