nasopharyngeal carcinoma
Conditions
Interventions
treatment group:Tirelizumab combined with GP induction chemotherapy, sequential concurrent radiotherapy and chemotherapy, followed by tirelizumab maintenance therapy
Sponsors
The Second People's Hospital of Neijiang
Eligibility
Sex/Gender
All
Age
28 Years to 61 Years
Inclusion criteria
Inclusion criteria: 1. With the consent of the patient, the patient was diagnosed as nasopharyngeal carcinoma by pathology. 2. Aged 18-70, PS score is 0-1. 3. Locally advanced nasopharyngeal carcinoma (T4 or N3, staging standard is AJCC 8th version). 4. The patient has no history of immune diseases, immunodeficiency diseases, organ transplantation and other tumors. 5. No drugs for immune enhancement or suppression, glucocorticoids and non steroidal drugs have been used in recent three months. 6. Functions of important organs: WBC = 3.5 × 109/L, platelet PLT = 90 × 109/L, hemoglobin = 90g/L; Normal liver function (TBil, ALT, AST = 2.0 × ULN) Normal renal function (Ccr = 60ml/min or creatinine = 1.5 × ULN).
Exclusion criteria
Exclusion criteria: 1. Have received nasopharyngeal or cervical treatment (radiotherapy, chemotherapy or surgery) in the past. 2. Age > 65 years old or < 18 years old; 3. Basal cell or squamous cell skin cancer and cervical carcinoma in situ with a history of malignant tumor but with appropriate treatment Outside; 4. Have received chemotherapy, targeted therapy, immunotherapy, and other systemic anti-tumor treatments in the past; 5. Pregnancy or lactation (for women of childbearing age, pregnancy tests should be conducted and effective contraception should be emphasized during treatment); 6. Combine diseases or complications that may bring unacceptable risks or impacts, such as instability requiring treatment Definite heart disease, acute exacerbation of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization, active hepatitis, and mental diseases requiring treatment; 7. Serious damage to important organs such as liver, kidney and lung. 8. Have undergone major surgery (except diagnostic surgery) within 28 days before treatment, or are expected to undergo major surgery during the study period. 9. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis related to antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis; Patients with autoimmune related hypothyroidism who receive thyroid hormone replacement therapy with a stabilizer dose are eligible to participate in this study. Patients with type 1 diabetes who have been controlled after receiving a stable insulin treatment program are eligible to participate in this study. 10. Known to have a history of allergy to antineoplastic drugs. 11. Use drugs with immune enhancement or suppression, glucocorticoids and non steroidal drugs in recent three months. 12. Patients who have previously undergone allogeneic bone marrow transplantation or solid organ transplantation. 13. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia (i.e. bronchiolitis obliterans), idiopathic.Pneumonia history or chest CT scan during screening showed evidence of active pneumonia. 14. According to the judgment of the investigator, the subject has other factors that may cause him/her to be forced to terminate the study halfway, such as His serious illness (including mental illness) requires combined treatment, the laboratory test value is seriously abnormal, and family or social factors may affect the safety of the subject or the test data collection. 15. Other conditions that the investigator thinks are not consistent with the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Three year relapse free survival time;Three year overall survival rate;Toxic and side effect; | — |
Countries
China
Contacts
Public ContactHaijun Li
The Second People's Hospital of Neijiang
Outcome results
None listed