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TIP8. A Single-Arm Phase II Clinical Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma

Friday, March 6, 2026
3:59 PM - 4:04 PM MST
Location: Pan-Tumor HUB Zone
Background:

Multimodal therapy combining surgical resection and chemotherapy is the standard for resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC). Only 58% of patients with resectable or borderline resectable receive adjuvant therapy after upfront surgery, whereas neoadjuvant therapy enables approximately 75% to proceed to surgery and complete multimodal therapy. Current standard neoadjuvant chemotherapy regimens {i.e., modified Folinic acid, Fluorouracil, Irinotecan, Oxaliplatin (FOLFIRINOX) and gemcitabine nab-paclitaxel (GN)} achieve a major pathological response rate in 33% patients [SWOG S1505]. A phase Ib/II trial adding cisplatin to GN (GCN) in advanced PDAC noted a 71% objective response rate, including 8% complete responses. Another phase II study in advanced biliary tract cancer using the GCN regimen demonstrated improved median overall survival (19.2 months) and progression-free survival (11.8 months). We aim to evaluate GCN in the neoadjuvant setting for resectable and borderline resectable PDAC.


Methods:

This single-arm phase II trial (NCT06423326) evaluates the feasibility (completion of 4 cycles), safety and clinical response of neoadjuvant GCN in patients with resectable and borderline resectable PDAC. Patients receive gemcitabine 800 mg/m² IV (30 min), cisplatin 25 mg/m² IV (60 min), and nab-paclitaxel 100 mg/m² IV (30 min) on days 1 and 15 of each 28-day cycle for 4 cycles (8 total doses), followed by restaging and surgery if resectable. Eligibility criteria include age ≥18 years, ECOG 0–1, biopsy-confirmed PDAC (resectable/borderline resectable per NCCN) and adequate organ function.

The primary endpoint is clinical response (biochemical, radiographic, pathologic or stable disease without progression to unresectability). Secondary endpoints include R0 resection rate, nodal status, recurrence-free and overall survival and changes in tumor immune infiltration via multiplex immunohistochemistry on pre- and post-neoadjuvant specimens. Sample size (n=36) was determined using a single-stage design, with success defined as ≥75% of patients achieving clinical response, providing 80% power to detect a 20% improvement over historical rates (α=0.05). Enrollment began in July 2024 with 14 patients until October 10, 2025.

Learning Objectives:

  • Describe the rationale for evaluating gemcitabine, cisplatin, and nab-paclitaxel (GCN) as neoadjuvant therapy in resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).
  • Explain the design, eligibility criteria, and primary and secondary endpoints of the phase II trial assessing feasibility and clinical response of neoadjuvant GCN in PDAC.