PD-1 Monoclonal Antibody Combined With Gemcitabine and Cisplatin Followed by Selective Radiotherapy for Unresectable Locally Recurrent NPC

Exclusion Criteria

• •1. Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence
• •2. Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.
• •3. Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.
• •4. History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.
• •5. Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma/atopy.
• •6. Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms.
• •7. Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies/mL
• •8. Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative
• •9. HIV infection
• •10. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia).
• •11. Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis.
• •12. Major surgery within 4 weeks before enrollment, or unhealed surgical wound.
• •13. Pregnant or breastfeeding women, or those planning pregnancy during the study period.
• •14. Known allergy or hypersensitivity to study drugs or their excipients.
• •15. Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.