Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Eligible patients are randomized into the control group and the experimental group.

Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.

Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Inclusion criteria

• Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
• Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
• Cervical lymph node metastasis can be controlled locally;
• Aged 18 to 75 years;
• Informed consent forms signed to participate in the trial;
• Without distant metastasis;
• ≥6months from the accomplishment of radical radiation to recurrence
• previously only 1 course of radiotherapy;
• Sufficient organ function;
• ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.

Exclusion criteria

• Participate in other interventional clinical trials;
• Uncontrolled illnesses that interfere with the therapy;
• Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
• Any contradiction to surgery;
• With serious autoimmune disease;
• 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;
• Severe allergic reactions to other monoclonal antibodies;
• History of radioactive particle planting;
• Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
• Female patients who are at pregnancy or lactation;
• Other situations that the researchers believe not suitable for enrollment