NCT05222035

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

Camrelizumab Plus PEG-rhG-CSF in Recurrent/Metastatic NPC With First-line Treatment Failure

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PD-1 Inhibitor
• G-CSF

Interventions

Type	Name	Description
DRUG	Camrelizumab	PD-1 inhibitor: Camrelizumab, 200 mg, intravenously (IV) , Day 1, Q3W, until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years).
DRUG	G-CSF	G-CSF: mecapegfilgrastim, 6 mg, subcutaneous injection, Day 1, Q3W, until stop using Camrelizumab, progressive disease (PD) or unacceptable toxicity.

Timeline

• Start date: 2022-01-24
• Primary completion: 2022-12-24
• Completion: 2023-06-01
• First posted: 2022-02-03
• Last updated: 2022-02-03

Locations

1 site across 1 country: China