Apartinib in combination with S-1 for the second-line treatment of advanced pancreatic cancer (APC).
TPS781 Background: The prognosis for patients with advanced pancreatic cancer (APC) is extremely dismal. First-line treatment for APC is gemcitabine/5-FU-based chemotherapy with no standard second-line treatment. Anti-angiogenic therapy combined with chemotherapy have showed its effects in improving the outcomes in a variety of cancers. Apatinib is an oral tyrosine kinase inhibitor that selectively targets VEGFR2. Some preclinical studies and several case reports showed the anti-tumor effect of apatinib in pancreatic cancer, but there is no evidence from clinical trial to confirm it. This study aims to evaluate the efficacy and safety of apartinib in combination with S-1 as the second-line therapy for patients with APC. Methods: In this open-label, single-arm, randomized phase II study, we will recruit 30 patients with pathologically proven advanced pancreatic cancer after the failure of first-line chemotherapy. All patients are aged 18-70 years with ECOG PS 0-2 and will receive apatinib at an initial dose of 500mg/d on a continuous basis, and oral S-1 (60mg/d for BSA < 1.25m2, 80mg/d for 1.25<BSA < 1.5m2, and 100mg for BSA >1.5m2, orally) twice a day on days 1-14 of a 21-day cycle. Primary endpoint is PFS. Secondary endpoints include OS, duration of response, ORR and DCR. The safety of apartinib + S-1 will be evaluated by CTCAE v4.0. Translational research will be performed in blood (before and on-treatment): cytokine panel to explore predictive and prognostic biomarkers. Clinical trial information: NCT03662035.