Efficacy and Safety of Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma: A Single-arm, Open-label, Multi-center Phase II Clinical Trial
The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.
• Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy. If the patient refuses biopsy of metastatic lesions, those diagnosed with metastasis based on imaging evidence and clinical evidence can be enrolled.
• Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence and metastases within 6 months after treatment of platinum-based chemoradiation.
• Age ≥ 18 years and ≤ 75 years, both genders.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• The life expectancy of at least 3 months.
• Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
• 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; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine \[FT3\] or free Thyroxine \[FT4\] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN.
• All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative.
• Written informed consent.