To evaluate the efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Secondary endpoints included 2-year overall survival (OS), distant failure-free survival (DFFS), locoregional failure-free survival (LRFFS), and adverse events.
Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma;
Age≥18 years;
Staging TanyN3M0 (AJCC/UICC 9th edition) ;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
HBsAg positive and HBV DNA >1×103 copy/ml;
Patients with positive HCV antibody test results;
Active, known, or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, or hair loss, may be enrolled;
History of interstitial lung disease;
Parallel
Sintilimab
DrugInduction chemotherapy stage: Sintilimab combined with GP regimen chemotherapy; Adjuvant chemotherapy stage: Sintilimab combined with Capecitabine
Failure-free survival
Overall survival
Distant failure-free survival
Locoregional failure-free survival
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