Nab-paclitaxel plus S-1 induction chemotherapy for patients with locally advanced pancreatic cancer: a multicenter, open-label phase 2 study.

Locally advanced pancreatic cancer (LAPC) is associated with a poor prognosis and limited therapeutic options. This study aimed to evaluate the efficacy and safety of nab-paclitaxel plus S-1 (SnP) as a first-line treatment in patients with previously untreated LAPC. In this multicenter, single-arm phase 2 trial conducted across four centers in China, eligible patients received up to eight cycles of nab-paclitaxel combined with S-1, followed by investigator-selected continuation strategies in the absence of disease progression or intolerable toxicity. The primary endpoint was the 6-month progression-free survival (PFS). Between April 2019 and March 2023, 60 patients were enrolled, of whom 48.3% completed induction therapy and 18.3% subsequently underwent surgical resection, with 10 achieving R0/R1 status. The 6-month PFS rate was 71.0% (95% CI: 57.6%-80.9%), while the median PFS and overall survival (OS) were 11.1 months and 20.2 months, respectively. The 12-month OS rate reached 83.3%. The objective response rate was 26.7%, and the disease control rate was 90.0%. Grade ≥3 treatment-related adverse events occurred in 53.3% of patients, most commonly neutropenia and leukopenia, with no treatment-related deaths observed. These findings suggest that SnP demonstrates promising antitumor activity with manageable toxicity in LAPC and may facilitate conversion to surgical resectability in a subset of patients. This clinical study was registered at ClinicalTrials.gov (NCT03885219).