Status:
UNKNOWN
G-CSF in Patients With Anti-PD-1-axis Therapy-resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Granulocyte Colony-Stimulating Factor
PD-1 Inhibitor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 chem...
Eligibility Criteria
Inclusion
- Male or female; 18-75 years of age.
- Subjects diagnosed with pathological confirmed non-keratinizing (WHO-II/III) metastatic NPC, or subjects with recurrent NPC that is unfit for local treatment
- Received prior treatment with platinum agents and PD-(L)1 inhibitors.
- 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).
- 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
- Known history of any ≥ grade 3 immune-related toxicity.
- Known history of hypersensitivity to any components of the PEG-rhG -CSF formulation.
- Received G-CSF concurrent with anti-PD-(L)1 antibody combined with anti-target agent (VEGFR/EGFR TKI/Ab) maintenance therapy. (Patients who received G-CSF to prevent and treat febrile neutropenia secondary to chemotherapy are permitted)
- 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.
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05222009
Start Date
January 24 2022
End Date
August 1 2023
Last Update
February 3 2022
Active Locations (1)
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1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060