Overview
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.
Eligibility
Inclusion Criteria:
- Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- 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).
- Aged 18-65;
- At least one measurable tumor lesion;
- PS (ECOG standard) 0-1;
- Adequate hematopoietic function: WBC3.5109/L, Hb100g/L, PLT100109/L;
- Normal liver and kidney functions: ALT/AST < 2.5 times the upper limit of normal value (ULN), total bilirubin < 1.5ULN;Serum creatinine < 1.5ULN;
- Expected survival period 6 months;
- Signing informed consent;
- Follow up regularly and comply with test requirements.
Exclusion Criteria:
- Patients with distant organ metastasis;
- Recurrent nasopharyngeal carcinoma;
- Creatinine clearance rate <60ml/ min;
- Have received chemotherapy, radiotherapy or targeted therapy;
- Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
- Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
- Active systemic infection;
- History of serious lung or heart disease;
- Drug or alcohol abuse;
- No or limited capacity for civil conduct;
- 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;
- Receive chronic systemic immunotherapy or hormone therapy outside the study;
- Pregnancy or lactation period;
- Patients receive blind treatment in other clinical studies.