drugset / Trial / NCT06158919
A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC. Eligible enrolled patients received 6 cycles of combined treatment with fuquinitinib combined with PD-1 inhibitor and chemotherapy (XELOX/SOX) regimen. Maintenance treatment was fuquinitinib combined with PD-1 inhibitor and Teghio/capecitabine until disease progression or toxicity became intolerable. The longest duration of PD-1 inhibitor treatment is 24 months.
Timeline
- Start
- 2023-11-20
- Primary completion
- 2024-11-20
- Completion
- 2026-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Fruquintinib | Small molecule | 4 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 40 mg/m2 | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |