Advanced recurrent nasopharyngeal carcinoma
Conditions
Interventions
Control group:Endoscopic surgery + adjuvant therapy
Experimental group:Neoadjuvant therapy +endoscopic surgery + adjuvant therapy
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma; 2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid =5mm) or rT3 (not confining to the bottom wall of sphenoid sinus), rT4, according to AJCC 8th edition; 3. Cervical lymph node metastasis can be controlled locally; 4. Aged 18 to 75 years; 5. Informed consent forms signed to participate in the trial; 6. Without distant metastasis; 7. >=6months from the accomplishment of radical radiation to recurrence; 8. previously only 1 course of radiotherapy; 9. Sufficient organ function:Hematology: Leukocytes>=3. 0 x 10^9/L, absolute neutrophil count >=1.5x 10^9/L, hemoglobin >=80 g/L, platelets >=100 x 10^9/L; Liver function: bilirubin <=1.5 times the upper limit of normal (ULN), AST and ALT <=3 times ULN c) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) <=1.5 times ULN d) Renal function: serum creatinine <= 1.5 times ULN; 10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.
Exclusion criteria
Exclusion criteria: 1. Participate in other interventional clinical trials; 2. Uncontrolled illnesses that interfere with the therapy; 3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.); 4. Any contradiction to surgery; 5. With serious autoimmune disease; 6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration; 7. Severe allergic reactions to other monoclonal antibodies; 8. History of radioactive particle planting; 9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period; 10. Female patients who are at pregnancy or lactation; 11. Other situations that the researchers believe not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DMFS;EFS;2 year PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological remission;OS;DFS;Complete pathological remission rate;Effectiveness metrics(ORR,DCR,DoR);LRFS;ORR;Treatment associated side effect;Pathological no remission;2 year OS rate;Pathological partial remission;1 year OS rate; | — |
Countries
China
Contacts
Public ContactYu Hongmeng
Eye & ENT Hospital of Fudan University
Outcome results
None listed