Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
• Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
• staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
• Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
• Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
• With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
• With normal renal function test ( creatinine clearance ≥60 ml/min)
• sign an informed consent form
• Male and no pregnant female