This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.
Age: 18 - 65 years old
Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.
AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.
Baseline plasma EBV-DNA > 0, and able to complete dynamic monitoring according to the protocol.
Clinical or imaging examinations have confirmed distant metastasis.
Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia).
Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection.
Parallel
Observation
Other interventionClinical follow-up and surveillance only.
Adjuvant therapy
DrugCapecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles
Adjuvant therapy
DrugTislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles（Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles）
2-year Failure Free Survival, 2-y FFS
calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause，whichever comes earlier.
Overal Survival，OS
calculated from the date of diagnosis of NPC to the date of death from any cause
Locoregionally Failure Free Survival，LRFFS
calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier.
Distant failure free survival, DFFS
calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
Adverse effects (AE)
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