A Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Sintilimab Plus Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
This randomized clinical trial determining whether Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of NPC patients with unfavorable response to induction chemotherapy. Patients whose plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST1.1 after two cycles induction chemotherapy will have concurrent chemoradiotherapy. MRI, CT and EBV DNA will be assessed before the end of radiotherapy. After concurrent chemoradiotherapy, eligible patients will be randomized to receive either adjuvant Sintilimab plus Capecitabine or Capecitabine alone.
• Histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
• Tumor staged as II-IVa (AJCC 8th,excluding T2N0 disease).
• Age ≥ 18 years and ≤ 70 years, both genders.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• Patients with plasma EBV DNA\> 0 copy/mL or PD/SD according to RECIST1.1 after two cycles of induction chemotherapy.
• Completed protocol-specified curative chemoradiotherapy, including two cycles of induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy( at least 2 cycles of concurrent cisplatin chemotherapy).
• Completion of the last radiation dose within 1 to 7 days before randomization
• No progression after prior cCRT
• Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
⁃ Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
⁃ Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
⁃ Patients must be informed of the investigational nature of this study and give written informed consent.
⁃ Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.