NCT05222009

G-CSF in Patients With Anti-PD-1-axis Therapy-resistant Recurrent or Metastatic Nasopharyngeal Carcinoma

Adding G-CSF in Patients With Anti-PD-1-axis Therapy-resistant Recurrent or Metastatic

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (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. Immunotherapy is an emerging cancer treatment method, which has less adverse reactions and longer duration compared with chemotherapy. At present, there are a large number of PATIENTS with anti-PD-1 resistance in clinical practice, who are faced with a significant decline in the efficacy of anti-PD-1 after treatment. However, without the synergistic effect of anti-PD-1, survival after chemotherapy alone will be significantly shortened. how to improve the efficacy of immunotherapy rechallenge so that a large number of potential patients can benefit from immunotherapy is an urgent problem to be solved at present. 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, thus regulate the immune status of tumor patients. Therefore, G-CSF may have a synergistic effect on anti-PD-1. This study intends to explore whether the addition of G-CSF can restore the efficacy of anti-PD-1 in drug-resistant NPC patients through a prospective clinical trial.

Conditions

• Granulocyte Colony-Stimulating Factor
• PD-1 Inhibitor

Interventions

Type	Name	Description
DRUG	PEG-rhG-CSF	PEG-rhG-CSF, 3mg, D1, Q3W, subcutaneous injection, until stop using PD-(L)1 inhibitor, progressive disease (PD) or unacceptable toxicity. Meanwhile, the original maintenance regimen--PD-(L)1 inhibitor ± VEGFR/EGFR TKI/Ab--continues.
DRUG	PEG-rhG-CSF	PEG-rhG-CSF, 6mg, D1, Q3W, subcutaneous injection, until stop using PD-(L)1 inhibitor, progressive disease (PD) or unacceptable toxicity. Meanwhile, the original maintenance regimen--PD-(L)1 inhibitor ± VEGFR/EGFR TKI/Ab--continues.

Timeline

• Start date: 2022-01-24
• Primary completion: 2022-11-01
• Completion: 2023-08-01
• First posted: 2022-02-03
• Last updated: 2022-02-03

Locations

1 site across 1 country: China