drugset / Trial / NCT05721651
Efficacy and Safety of Fruquintinib in Combination With PD-1 Inhibitors as First-line Maintenance Therapy for Advanced HER-2 Negative Gastric Cancer: a Single-arm, Prospective, Exploratory Clinical Study
NaSingle-groupOpen-labelTreatment
Summary
Maintenance therapy is very important in advanced HER-2 negative gastric cancer, and immune monotherapy has no obvious benefit in the first-line maintenance treatment of advanced gastric cancer； Fruquintinib is a potent small-molecule VEGFR inhibitor with high kinase selectivity；Studies have shown that immunotherapy combined with antiangiogenic agents is promising for synergistic antitumor effects； The aim of this study was to observe and evaluate the efficacy and safety of Fruquintinib combined with PD-1 inhibitor in the first-line maintenance treatment of advanced HER-2 negative gastric cancer.
Timeline
- Start
- 2023-04
- Primary completion
- 2025-03
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fruquintinib | Small molecule | 4 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |