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PPS44. A window-of-opportunity trial using neoadjuvant hepatic artery chemotherapy for patients with localized pancreas cancer: Safety, feasibility, and interim oncologic outcomes

Friday, March 6, 2026
3:40 PM - 4:10 PM MST
Location: HUB Poster Park - West Hall 1-3
Introduction:

Recurrence rates are high among patients with pancreatic ductal adenocarcinoma (PDAC) undergoing curative-intent therapy. The liver is the most common site of recurrence and is associated with the worst survival outcomes. In localized colorectal cancer, single-dose neoadjuvant hepatic artery (HA) chemotherapy has improved liver metastasis-free (LMFS) and overall survival (OS). Since PDAC and colorectal cancer have similar recurrence patterns and use similar systemic therapies, we hypothesized this strategy would be safe, feasible, and potentially improve recurrence rates and overall survival in patients with PDAC.


Methods:

This prospective, non-randomized trial aimed to enroll 20 patients with localized PDAC undergoing curative-intent therapy. Patients received a single HA chemotherapy dose (floxuridine 325 mg/m2 and oxaliplatin 37.5 mg/m2) one week before resection (Fig. 1A). Patients were evenly assigned to (1) upfront surgery followed by 12 cycles of mFOLFIRINOX, or (2) 4-8 cycles of neoadjuvant mFOLFIRINOX, followed by surgery and completion of therapy postoperatively. All underwent diagnostic laparoscopy and percutaneous delivery of HA chemotherapy one week before surgery. The primary endpoint was 30-day safety and feasibility. Secondary endpoints were three-year disease-free survival (DFS), LMFS, and OS.


Results:

Among 36 patients screened, 20 were enrolled, ten in each arm. Median age [IQR] was 68.5 [64.5-72.5] years and 55% were female. Fifteen patients (75%) were White and three (15%) were Black. Median preoperative CA 19-9 [IQR] was 32.5 [22.5-65.8] U/mL. HA chemotherapy was successfully administered in 19 patients (95%), with delivery through the proper HA in 55%, and separately through the right and left HAs in 45%. Accessory HA ligation/embolization was required in 35%. Median tumor size was 2.9 cm and lymph node metastases were present in 58%; five patients (20%) had microscopically positive resection margins. Nine patients (45%) experienced adverse events, however, none were attributed to the experimental therapy (Fig. 1B). At a median follow up of 8.7 months, 18 patients (90%) are alive (median OS not reached). Seven (35%) recurred (median DFS 20.8 months, 95% CI 12.8-undefined), including four with liver metastases (median LMFS 20.8 months, 95% CI 12.8-undefined).  


Conclusions:

Single-dose neoadjuvant HA chemotherapy is safe and feasible in patients undergoing resection of localized pancreatic cancer. Long-term follow-up is ongoing to measure three-year survival endpoints.

Learning Objectives:

  • Understand the design and implementation of our phase II, non-randomized, prospective, window-of-opportunity clinical trial in 20 patients with localized pancreas cancer.
  • Appreciate the safety and feasibility of single-dose, neoadjuvant hepatic artery chemotherapy for patients with localized pancreas cancer.