nasopharyngeal carcinoma
Conditions
Interventions
Group A:Conventional radiotherapy + Thymopentin group
Group B:Conventional radiotherapy group
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years old; 2.Patients with locally advanced nasopharyngeal carcinoma initially treated as confirmed by histopathology; 3.Those who have not used hormone or immunosuppressant treatment within two weeks; 4.Female patients who are of childbearing ability must meet the following requirements: negative blood or urine HCG test before enrollment in the trial. 5,.1 week before enrollment, the subject's bone marrow, liver and kidney function to meet the following criteria and exclude the effect of the white needle: a. Hemoglobin = 90g/L, neutrophil = 1.5*109/L, platelet = 100*109/L; b . Total bilirubin =1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine transferase (ALT) =1.5 times the upper limit of normal; c . Serum creatinine =1.5 times the upper limit of normal value or creatinine clearance =60 ml/min and urea nitrogen =200 mg/L; d . International normalized ratio (INR) or prothrombin time (PT) =1.5 times the upper limit of normal value.
Exclusion criteria
Exclusion criteria: 1, Allergy to known experimental drugs; 2, Patients with recurrent/metastatic nasopharyngeal cancer; 3, Those with other malignant tumors; 4, Those with any known disease that severely affects the immune system, e.g., history of infection with Human Immunodeficiency Virus (HIV) or splenectomy, etc. or history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, or a history of organ transplantation; 5, Any unstable systemic disease: including active infection, active tuberculosis, uncontrolled hypertension, congestive heart failure, myocardial infarction, severe arrhythmia requiring medication, hepatic renal or metabolic disease, neurologic/psychiatric disease such as Alzheimer's disease; 6. other conditions deemed by the investigator to be unsuitable for participation in this clinical trial, such as poor compliance; 7, Patient refusal to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre- and post-radiotherapy changes in T-cell subsets (CD3, CD4, CD8, CD4/CD8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients' quality of life scores;Restoration of oral mucosa; | — |
Countries
China
Contacts
Public ContactXiaoshen Wang
Eye & ENT Hospital of Fudan University
Outcome results
None listed