Nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Toripalimab monoclonal antibody and modified TPF regimen
Sponsors
Yulin First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis of non-keratosis nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III). 2. The stage is IVa stage (8th UICC/AJCC stage, excluding T4N0) for the first treatment of nasopharyngeal carcinoma patients. 3. Men or non-pregnant women. 4. Aged 18-65 years. 5. The general situation is good, and the ECOG score is 0-1. 6. Hemoglobin (HGB) >=90 g/L, white blood cell (WBC) >=4x10^9 /L, platelet (PLT) >=100x10^9 /L. 7. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) =60ml/min or serum creatinine <1.5xULN. 9. The patient has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. History of severe hypersensitivity to other monoclonal antibodies or any component of PD-1 monoantibody; 2. Patients with other malignant tumors; 3. Patients with known or suspected autoimmune diseases, including dementia and seizures; 4. Severe mental illness at the same time; 5. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [can be included after normal hormone replacement therapy]); Patients with vitiligo or complete remission of asthma in childhood and without any intervention in adulthood could be included, but patients with asthma requiring medical intervention with bronchodilators could not be included; Patients who use hormones (except for topical use) for these or other reasons; 6. Within 4 weeks prior to the first use of the investigational drug (calculated as the last use of the investigational drug or device for subjects in the follow-up period) or currently participating in another clinical study; 7. HIV positive patients; 8.HBsAg positive and HBV DNA copy number positive (quantitative detection >=1000cps/ml); 9. Positive blood screening for chronic hepatitis C (HCV antibody positive); 10. Received any anti-infective vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment; 11. Lactating patients; 12. The investigators judged that the patients were not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival;Security; | — |
Countries
China
Contacts
Public ContactLiang Leifeng
The First People's Hospital of Yulin
Outcome results
None listed