Apact: A Phase 3 Randomized, Open-Label, Multicenter Trial Evaluating The Use Of Adjuvant Nab-Paclitaxel (Nab-P) Plus Gemcitabine (G) Versus G Alone In Patients (Pts) With Surgically Resected Ductal Pancreatic Adenocarcinoma (Pda).

TPS4162^ Background: Resection is the only curative treatment for PDA. Adjuvant chemotherapy following resection is associated with improved disease-free survival (DFS), median overall survival (OS), and 5-year survival for pts with resectable PDA. Despite these improvements, recurrence rates are still high, and survival rates remain poor, requiring more effective adjuvant therapies. In the phase 3 MPACT trial, nab-P plus G was manageable and demonstrated superiority to G alone for OS (median 8.5 vs 6.7 months; HR 0.72; 95% CI, 0.617 - 0.835; P u003c 0.001) and all secondary efficacy endpoints in pts with metastatic PDA [Von Hoff et al. N Engl J Med. 2013]. The current phase 3 trial (APACT) will evaluate the efficacy and safety of nab-P plus G vs G alone as adjuvant chemotherapy in pts with surgically resected PDA. Methods: Approximately 800 eligible pts will be randomized 1:1 (stratified by resection status [R0 vs R1], lymph node status [positive vs negative], and region) to receive nab-P 125 mg/m2 plus G 10...