Adjuvant vs Surgery Only in Early-stage Recurrent NPC

This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.

Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Inclusion criteria

• Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
• Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery >5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
• Cervical lymph node metastasis can be controlled locally
• Age 18 to 75 years;
• Without distant metastasis;
• Informed consent forms signed;
• ≥6months from the accomplishment of radiation to recurrence
• previously radiotherapy for only 1 course;
• ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
• Sufficient organ function;
• Undergone endoscopic surgery with negative pathological margin;

Exclusion criteria

• Participation in other interventional clinical trials;
• Uncontrolled illnesses which will interfere with the ability to undergo therapy;
• Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
• Any contradiction to immune and chemotherapy;
• With serious autoimmune disease;
• Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
• 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 are not suitable for enrollment