Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

Single Arm, Open, Multicenter Phase II Clinical Study of Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in patients with N3.

Inclusion Criteria:

1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
2. No distant metastatic stage N3 nasopharyngeal carcinoma was first diagnosed (according to the 8th edition UICC/AJCC nasopharyngeal carcinoma staging system defined as any T and N3M0 stage nasopharyngeal carcinoma).
3. Aged 18-65;
4. At least one measurable tumor lesion;
5. PS (ECOG standard) 0-1;
6. Adequate hematopoietic function: WBC≥3.5×109/L, Hb≥100g/L, PLT≥100×109/L;
7. Normal liver and kidney functions: ALT/AST < 2.5 times the upper limit of normal value (ULN), total bilirubin < 1.5×ULN;Serum creatinine < 1.5×ULN;
8. Expected survival period ≥6 months;
9. Signing informed consent;
10. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Patients with distant organ metastasis;
2. Recurrent nasopharyngeal carcinoma;
3. Creatinine clearance rate <60ml/ min;
4. Have received chemotherapy, radiotherapy or targeted therapy;
5. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
7. Active systemic infection;
8. History of serious lung or heart disease;
9. Drug or alcohol abuse;
10. No or limited capacity for civil conduct;
11. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
12. Receive chronic systemic immunotherapy or hormone therapy outside the study;
13. Pregnancy or lactation period;
14. Patients receive blind treatment in other clinical studies.