Single-center phase 2 trial of first-line sintilimab plus intraperitoneal and intravenous chemotherapy for gastric cancer with peritoneal metastasis

The phase 2 DRAGON-09 trial at Shanghai Jiao Tong University School of Medicine (China) evaluated sintilimab plus intraperitonal and intravenous chemotherapy as first-line treatment for gastric cancer with peritoneal metastasis (GCPM). Thirty-eight CCPM patients received three-week cycles of intravenous sintilimab on day 1, oral S-1 twice daily on days 1-14, and intraperitoneal and intravenous paclitaxel on days 1 and 8. Objective response rate was 57.0% and disease control rate was 94.7%. One-year overall survival rate (primary endpoint) was 76%. The median progression-free survival was 14.6 months (95% CI 10.0-NR) and the median overall survival was 18.4 months (15.0-NR). The most common treatment-related adverse events were anemia, elevated glutamic oxaloacetic transaminase, and leukopenia. The authors conclude that first-line sintilimab and S-1 plus intraperitoneal and intravenous paclitaxel showed promising efficacy in patients with GCPM.