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.
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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