sinonasal malignant mucosal melanoma
Conditions
Interventions
immunity treatment combined with radiation and chemotherapy:endoscopic therapy, immunity treatment,radiation,chemotherapy
Sponsors
Eye, Ear, Nose and Throat Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathologically diagnosed as sinonasal malignant mucosal melanoma, locally resectable and no contraindication for surgery or radiation; 2.T3 and T4; 3.Aged >=18 years; 4.No distant metastasis; 5.No head and neck radiation and systemic anti-tumor therapy performed in the past 5 years; 6.The performance status of the Eastern Cooperative Oncology Group(ECOG) is 0-2 points and surgery after general anesthesia and postoperative radiation could be tolerated; 7.Accepted organ function.
Exclusion criteria
Exclusion criteria: 1. Patients who refused to sign informed consent; 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 |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| side effects of treatment;3-year progression-free survival rate;Local progression-free survival, LPFS;regional progression-free survival, RPFS;distant metatasis-free survival, DMFS ; | — |
Countries
China
Contacts
Public ContactHongmeng Yu
Outcome results
None listed