Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer

Summary

Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies

Timeline

Start

2024-02-28

Primary completion

2026-06-28

Completion

2028-06-28

Publications

• Chen B, Zhao J, Lv H, Xu W, Wang J, Nie C, He Y, Zhang B, Huang J, Liu Y, Ma F, Zhang H, Guo Y, Liu Y, Li P, Chen X, Chen X. Single-arm, open-label, multicentre phase 1b/2 study to evaluate the safety and efficacy of fruquintinib combined with sintilimab and CAPEOX as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma (FUNCTION study): a study protocol. BMJ Open. 2025 Sep 26;15(9):e100241. doi: 10.1136/bmjopen-2025-100241.

Drugs

Indications