drugset / Trial / NCT05222035

PD-1 Inhibitor Plus G-CSF in Recurrent/Metastatic NPC With First-line Treatment Failure

NCT05222035

Phase 2 Unknown 68 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

Recurrence and metastasis are the main causes of treatment failure of NPC. Preliminary clinical studies have found that the overall response rate of PD-1 inhibitors in treating ≥2 line R/M NPC is about 25%. Recent studies have shown that G-CSF can significantly increase the proportion of effector cells dominated by CD4+ T cells, improve the diversity of peripheral blood TCR, and regulate the immune status of patients. Therefore, we suspect that G-CSF may have a synergistic effect on PD-1 inhibitor, thus enhance the efficacy of PD-1 inhibitor monotherapy.

Timeline

Start
2022-01-24
Primary completion
2022-12-24
Completion
2023-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Mecapegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications

No indication recorded.