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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    68
  • sponsor
    Sun Yat-sen University
Updated on 22 March 2022

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.

Details
Condition PD-1 Inhibitor, G-CSF
Treatment G-CSF, Camrelizumab
Clinical Study IdentifierNCT05222035
SponsorSun Yat-sen University
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female; 18-75 years of age
Received one or more lines of therapy, which must include prior treatment with a platinum agent (except for patients who are unfit or refuse platinum-containing regimens) and must not be amenable to potentially curative radiotherapy or surgery. [Received neoadjuvant/adjuvant/concurrent platinum-containing regimen for radical therapy (radiotherapy or surgery), with recurrence ≤6 months following completion of therapy can be recognized as one line]
Subjects diagnosed with pathological confirmed non-keratinizing (WHO-II/III) metastatic NPC, or subjects with recurrent NPC that is unfit for local treatment
Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria
ECOG performance status of 0 or 1
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
Life expectancy more than 12 weeks
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
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
Be willing and able to provide written informed consent/assent for the trial

Exclusion Criteria

Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway)
Known history of hypersensitivity to any components of the Camrelizumab and PEG-rhG -CSF formulation or other monoclonal antibodies
Prior chemotherapy, targeted small molecule therapy, or radical therapy within 2 weeks prior to Study Day 1
Diagnosed and/or treated additional malignancy within 5 years of enrollment, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration
Active central nervous system metastases and/or carcinomatous meningitis
Severe, uncontrolled angiocardiopathy (heart failure > class II NYHA, unstable angina, myocardial infarction within past 1 year, supraventricular or ventricular arrhythmia which need medical intervention, or QT interval male ≥ 450 ms, female ≥ 470 ms.)
History of non-infectious pneumonitis that required steroids or current pneumonitis
Active infection requiring systemic therapy
Be known to have active tuberculosis
Human immunodeficiency virus (HIV) positive
Hepatitis B or C positive
Live vaccine within 30 days of planned start of study drug
Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events
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