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

Inclusion Criteria

• •1. Male or female; 18-75 years of age.
• •2. Subjects diagnosed with pathological confirmed non-keratinizing (WHO-II/III) metastatic NPC, or subjects with recurrent NPC that is unfit for local treatment
• •3. Received prior treatment with platinum agents and PD-(L)1 inhibitors.
• •4. Developed acquired resistant (AR) to PD-(L)1 inhibitors following the anti-PD-1/L1 or combined with anti-target agent (VEGFR/EGFR TKI/Ab) maintenance therapy. (AR defined as disease progression after partial or complete response).
• •5. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
• •6. ECOG performance status of 0 or 1.
• •7. Have recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to any anti-tumor therapy 4 weeks earlier. Except for hair loss, hair color change, nail change, fatigue, etc., which do not pose safety risks to subjects.
• •8. Life expectancy more than 12 weeks.
• •9. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by:
• •Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN ; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; INR, APTT≤1.5 x ULN.
• •10. Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy.
• •11. Be willing and able to provide written informed consent/assent for the trial.