A phase II multicenter study of NASOX regimen as adjuvant chemotherapy for patients with resected pancreatic ductal adenocarcinoma.

Abstract

4230 Background: Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related mortality in China, with a 5-year survival rate of only 5%–7%. Surgical resection followed by adjuvant chemotherapy can improve this to 15%–25%, but more effective adjuvant regimens are urgently needed to further prolong survival. The PRODIGE 24/CCTG PA.6 trial demonstrated that the mFOLFIRINOX regimen significantly improved outcomes compared with gemcitabine alone. The NASOX regimen is a modified mFOLFIRINOX regimen, which uses irinotecan hydrochloride liposomes (nal-IRI) instead of irinotecan and oral fluoropyrimidine tegafur instead of fluorouracil, and has demonstrated a favorable safety profile. This study aims to assess the efficacy and safety of NASOX as an adjuvant chemotherapy regimen for patients with resected PDAC. Methods: This is a Phase II, single-arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of NASOX as adjuvant chemotherapy in patients with resected PDAC. The primary endpoint is DFS. Secondary endpoints include overall survival (OS), safety, quality of life (QoL), compliance with adjuvant therapy, and nutritional status. Exploratory endpoints will involve genomic, metabolomic, and proteomic analyses to identify biomarkers that may predict response and safety to NASOX regimen Results: Between August 2024 and October 2025, 55 patients were screened, with 53 ultimately enrolled. Age ranged from 34 to 73 years (median: 59). Forty-six patients underwent at least one tumor assessment, with 11 experiencing disease recurrence and 3 deaths. Median follow-up was 11.5 months(interquartile range 9.9–15.5), yielding a 9-month DFS rate of 82.7% a 9-month OS rate of 97.7%, with median DFS and OS not yet reached. Treatment-related adverse events (TRAEs) occurred in 52 patients (100%), including grade 3 or 4 adverse events in 28 patients (53.85%). The most common Grade 3–4 treatment-related adverse events were diarrhea (17.31%), neutropenia (17.31%), hypokalemia (11.54%), and gastrointestinal pain (9.62%). Conclusions: NASOX regimen demonstrated the anticipated efficacy and safety profile in the adjuvant treatment of PDAC following surgery, warranting further investigation. Clinical trial information: NCT06361316 .