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

NCT06158919

Recruiting 58 enrolled Fudan University
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

EvaluationDrugModalityDoseRoute
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