Recurrent nasopharyngeal carcinoma
Conditions
Interventions
Group 1:Nasal endoscopic surgery combined with PD-1 inhibitor
Sponsors
Eye, Ear, Nose, and Throat Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathology or radiography confirmed recurrent nasopharyngeal carcinoma; 2. AJCC rT1-T4 which can be surgically removed; 3. Age >=18 years old; 4. Informed consent signed; 5. With or without lymph node metastasis, which can be surgically removed; 6. No distant metastasis; 7. >=6 months from initial radiotherapy to recurrence; 8. Sufficient organ function: (1) Hematology: white blood cells >=3.0*10^9/L, absolute neutrophil count >=1.5*10^9/L, hemoglobin >=80 g/L, platelets >=100*10^9/L. (2) Liver function: bilirubin <= 1.5 times the upper limit of normal (ULN), AST and ALT <= 3 times the ULN; (3) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) <= 1.5 times ULN; (4) Renal function: serum creatinine <= 1.5 times ULN; 9. ECOG score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy.
Exclusion criteria
Exclusion criteria: 1. Evidence of distant metastasis or leptomeningel disease (LMD); 2. Have received radioactive seed implantation in the treatment area; 3. Suffer from uncontrolled disease which could interfere with treatment; 4. Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.); 5. The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on; 6. The patients have autoimmune diseases; 7. The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration; 8. Severe allergic reaction to other monoclonal antibodies; 9. Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment; 10. Live vaccines have been inoculated within 4 weeks before the first administration or during the study period; 11. The patient has any situation that may hinder study compliance or the safety during the study period; 12. Existence of serious neurological or psychiatric diseases, such as dementia and seizures; 13. Uncontrolled active infection; 14. Pregnant or breastfeeding women; 15. Those who have no personal freedom and independent capacity for civil conduct; 16. There are other situations that are not suitable for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival;2-year local recurrence-free rate;2-year distant metastasis-free rate;treatment related adverse effect;immune related adverse effect;life quality; | — |
Countries
China
Contacts
Public ContactHongMeng Yu
Eye, Ear, Nose, and Throat Hospital, Fudan University
Outcome results
None listed