Nasopharyngeal
Conditions
Interventions
Auxiliary Treatment Group:chemotherapy+immune therapy
Control group:None
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. 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; 3. Cervical lymph node metastasis can be controlled locally; 4. 18 years old=6months from the accomplishment of radiation to recurrence; 8. previously radical radiotherapy for only 1 course; 9. ECOG score 0-2 and can tolerate chemotherapy and immunotherapy 10. Sufficient organ function; 11. Undergone endoscopic surgery with negative pathological margin;
Exclusion criteria
Exclusion criteria: 1. Participation in other interventional clinical trials; 2. Uncontrolled illnesses which will interfere with the ability to undergo 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); 4. Any contradiction to immune and chemotherapy; 5. With serious autoimmune disease; 6. 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; 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 are not suitable for enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence-free survival(LRFS);Overall survival;Distant metastasis-free survival; | — |
Countries
China
Contacts
Public ContactYu Hongmeng
Eye & ENT hospital of Fudan University
Outcome results
None listed