Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma
Trial Parameters
Brief Summary
This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.
Eligibility Criteria
Inclusion Criteria: 1. Age at diagnosis: 18 \~ 65 years old; 2. Pathologically confirmed primary nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)"; 3. Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) was diagnosed according to the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 8th edition clinical staging system. 4. Induction and concurrent chemoradiotherapy with the recommended regimen have been completed; 5. ECOG score: 0 \~ 1 points (Appendix II); 6. It is recommended to initiate adjuvant therapy within 1 month after the completion of the last radiotherapy treatment, no later than 6 weeks; 7. Normal bone marrow function: white blood cell count \> 4 × 109/L, hemoglobin concentration \> 90 g/L, platelet count \> 100 × 109/L; 8. Normal liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of normal; aspartate aminotransferase and/or a