Intraperitoneal and intravenous paclitaxel plus S-1 and sintilimab as first-line treatment for gastric cancer with peritoneal metastasis: a single-arm phase 2 trial (DRAGON-09).

ABSTRACT:

Background

First-line PD-1 blockade plus chemotherapy has shown significant clinical benefit in metastatic gastric cancer. This study aimed to evaluate the efficacy and safety of sintilimab and S-1 plus intraperitoneal and intravenous paclitaxel as first-line treatment for patients with gastric cancer peritoneal metastasis (GCPM), as well as exploratory predictive biomarker analysis.

Methods

We conducted a single-arm, phase 2 trial at a single centre in China between Jan 1, 2022, and Dec 31, 2023. Patients with laparoscopically confirmed GCPM were treated with sintilimab (200 mg IV on D1), S-1 (40-60 mg orally twice a day for D1-14), and paclitaxel (20 mg/m² intraperitoneally and 50 mg/m² IV on D1 and 8), in cycles every 3 weeks. The primary efficacy en

SUBMITTER: Yuan H 

PROVIDER: S-EPMC12803849 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature