recurrent nasopharyngeal carcinoma
Conditions
Interventions
Group One:camrelizumab,chemotherapy,endoscopic surgery
Sponsors
Eye and Ear Nose and Throat Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed recurrent nasopharyngeal carcinoma; 2. Patients with recurrent nasopharyngeal carcinoma: including rT2 (deep parapharyngeal space), rT3, rT4, and can be surgically removed; 3. Aged >= 18 years old; 4. Patients who signed informed consent to participate in the trial; 5. With/without lymph node metastasis, it can be surgically removed; 6. No risk of recent major bleeding; 7. No distant metastasis; 8. From the end of the initial radiotherapy to the recurrence of more than or equal to 6 months; 9. Only one time of radical radiotherapy has been performed; 10. Good organ function: (1) Hematology: white blood cells >=3.0 x 10^9/L, absolute neutrophil count >=1.5x 10^9/L, hemoglobin >=80 g/L, platelets >=100 x 10^9/L; (2) Liver function: bilirubin <= 1.5 times the upper limit of normal (ULN), AST and ALT <= 3 times 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; 11. The performance status of Eastern Cooperative Oncology Group (ECOG) is 0, 1, 2, and the general physical condition can tolerate general anesthesia surgery, chemotherapy and immunotherapy.
Exclusion criteria
Exclusion criteria: 1.With a history of allergic to platinum drugs and similar compounds; 2.Evidence of distant metastasis or radiation encephalopathy or leptomeningel disease (LMD); 3.Have received radioactive seed implantation in the treatment area; 4.Suffer from uncontrolled disease which could interfere with treatment; 5.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.); 6.The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on; 7.The patients have autoimmune diseases; 8.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; 9.Severe allergic reaction to other monoclonal antibodies; 10.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; 11. Live vaccines have been inoculated within 4 weeks before the first administration or during the study period; 12. The patient has any situation that may hinder study compliance or the safety during the study period; 13. Existence of serious neurological or psychiatric diseases, such as dementia and seizures; 14. Uncontrolled active infection; 15. Pregnant or breastfeeding women; 16. Those who have no personal freedom and independent capacity for civil conduct; 17. There are other situations that are not suitable for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;rate of margin negative;local recurrence free survival;distant metastasis free survival;pathologically complete remission;quality of life; | — |
Countries
China
Contacts
Public ContactYu Hongmeng
Eye and Ear Nose and Throat Hospital Affiliated to Fudan University
Outcome results
None listed