The phase I study is a dose-escalation study using a standard 3+3 design. The regimen involves 3-week cycles with escalated doses of nab-paclitaxel (80-120 mg/m2 on days 1 and 8) and fixed doses of sintilimab (200 mg on day 1) and S-1 (based on body-surface area on day 1 to 14). The primary endpoints are safety and determination the recommended dose in the subsequent phase II study. In the phase II trial, the primary endpoint is 3-year relapse-free survival (RFS). Secondary endpoints are 5-year overall survival (OS), 3-year OS, 5-year RFS, and quality of life. Exploratory endpoint is time to peritoneal metastasis. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.
In this study, we combine Nab-PTX, S-1 and sintilimab as adjuvant regimen to patients with stage IIIC GC. We are aiming to investigate the recommended dose of this regimen in a phase I study and estimate the toxicity and efficacy of this regimen in a phase II study.