A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma
The purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma. According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).
• Completed a definitive course of intensity-modulated photon radiation therapy (IMRT) to a total dose of ≥ 66 Gy
• Recurrence at nasopharynx diagnosed more than 6 months after the initial course of IMRT
• Patients with neck lymphadenopathy should receive neck dissection before randomization
• With measurable lesion on contrast MR scan
• Age ≥ 18 and \< 70 years of age
• ECOG score: 0-1
• Leucocyte count ≥ 4000/µL, neutrocyte count ≥ 2000/µL, platelet count ≥ 100000/µL, hemoglobin ≥ 90g/L
• Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN), alkaline phosphatase \< 2.5×ULN, bilirubin ≤ ULN, serum creatinine ≤ ULN, creatinine clearance ≥ 60ml/min
• Willing to accept adequate contraception
• Ability to understand the nature of the clinical trial and sign the written informed consent