Nasopharyngeal carcinoma
Conditions
Interventions
care of standard:Concurrent chemo-radio therapy+adjuvant chemotherapy
surgery:surgery+adjuvant chemotherapy
surgery combined toripalimab:surgery+chemotherapy+toripalimab injection
Sponsors
Eye, Ear, Nose and Throat Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathological evidence of NPC; 2. RECIST 1.1 criteria showed at least one measureble lesion; 3. Aged >= 18 years; 4. Clinical stageI and II; 5. Without previous treatment in any form. 6. No contradiction of radiotherapy or chemotherapy; 7. ECOG score 0 or 1; 8. Surgical resectable; 9.(ANC)> 1500 / mm3,(Hgb)> 8.0 g / dL,plt> 100,000 / mm3; 10. = 6 months. 13. Women of childbearing potential and sexually active malesable to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study.
Exclusion criteria
Exclusion criteria: 1. Refuse to sign inform consent. 2. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients. 3. Potential necrosis or any possibility for massive hemorrhage. 4. History of severe hypersensitivity reactions to other mAbs or any ingredient of Toripalimab Injection (JS001) . 5. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) receptor. 6. Distant metastases or leptomeningeal disease (LMD) . 7. Have uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy. 8. Have a history of a different malignancy, unless the disease has not progressed for >= 2 years. 9. Female patients who are at pregnancy or lactation. 10. Have any co-existing condition that would preclude full compliance with the study. 11. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. 12. Presence of a significant neurological or psychiatric disease, including dementia and seizures. 13. Have NCI-CTCAE >= Grade 2 peripheral neuropathy. 14. Any contradiction to surgery. 15. Attending other experimental trials. 16. Other situation not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;locoregional disease free survival; | — |
Countries
China
Contacts
Public ContactHongmeng Yu
Eye, Ear, Nose and Throat Hospital, Fudan University
Outcome results
None listed