A Multicenter, Randomized Controlled, Phase II Trail of Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA After Radiotherapy
This study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy.
• Age ≥18 years;
• Histologically confirmed nasopharyngeal carcinoma;
• Expected survival time ≥12 weeks;
• ECOG performance status: 0-1;
• Received definitive radiotherapy (± induction and/or concurrent chemotherapy);
• Plasma EBV DNA \>0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ;
• Adequate organ function meeting the following criteria: Hematological: a. Hemoglobin (HB) ≥90 g/L; b. Absolute neutrophil count (ANC) ≥1.0×10⁹/L; c. Platelet count (PLT) ≥80×10⁹/L; Biochemical: a. Total bilirubin (BIL) \<1.5× upper limit of normal (ULN); b. ALT and AST \<2.5×ULN; c. Serum creatinine (Cr) ≤ULN, and creatinine clearance rate ≥50 mL/min (calculated by Cockcroft-Gault formula); d. Normal myocardial enzymes and thyroid function; e. Normal cardiac function assessed by echocardiography.
• Signed informed consent with willingness to comply with the study protocol.