Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC

A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

Inclusion Criteria:

• Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
• AJCC rT1-T4 which can be surgically removed.
• Age ≥18 years old.
• Informed consent signed.
• With or without lymph node metastasis, which can be surgically removed.
• No distant metastasis.
• ≥6 months from the end of initial radiotherapy to recurrence.
• Sufficient organ function a)Hematology: white blood cells ≥3.0 x 109/L, absolute neutrophil count ≥1.5x 109/L, hemoglobin ≥80 g/L, platelets ≥100 x 109/L. b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times the 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.
• ECOG score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy.

Exclusion Criteria:

• Evidence of distant metastasis or leptomeningel disease (LMD).
• Have received radioactive seed implantation in the treatment area.
• Suffer from uncontrolled disease which could interfere with treatment.
• 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.).
• The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on.
• The patients have autoimmune diseases.
• 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.
• Severe allergic reaction to other monoclonal antibodies.
• 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.
• Live vaccines have been inoculated within 4 weeks before the first administration or during the study period.
• The patient has any situation that may hinder study compliance or the safety during the study period.
• Existence of serious neurological or psychiatric diseases, such as dementia and seizures.
• Uncontrolled active infection.
• Pregnant or breastfeeding women.
• Those who have no personal freedom and independent capacity for civil conduct.
• There are other situations that are not suitable for entry into the study.