The investigators plan to conduct a multicenter, prospective, single-arm phase II clinical trial of PD-1 monoclonal antibody combined with gemcitabine and cisplatin followed by selective radiotherapy for unresectable locally recurrent nasopharyngeal carcinoma to evaluate the efficacy and safety of PD-1 antibody plus GP chemotherapy followed by sequential selective radiotherapy in patients with unresectable locally recurrent disease who achieve tumor regression after immunochemotherapy, thereby providing evidence-based medical evidence for the treatment of unresectable locally recurrent NPC and improving treatment outcomes for these patients.
Age 18-70 years, any gender.
Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery.
Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).
Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.
Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence
Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.
Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.
History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.
Single group
PD-1 monoclonal antibody combined with gemcitabine and cisplatin followed by selective radiotherapy
Drug1. Gemcitabine + Cisplatin Chemotherapy: Gemcitabine 1000 mg/m² on days 1 and 8 + Cisplatin 80 mg/m² on day 1, every 3 weeks, for 4-6 cycles. PD-1 Monoclonal Antibody Immunotherapy: Toripalimab 240 mg on day 1, every 3 weeks, or Tislelizumab 200 mg on day 1, every 3 weeks, or Camrelizumab 200 mg on day 1, every 3 weeks, for 4-6 cycles. 2. PD-1 Maintenance Therapy: Toripalimab 240 mg on day 1, every 3 weeks, or Tislelizumab 200 mg on day 1, every 3 weeks, or Camrelizumab 200 mg on day 1, every 3 weeks, until disease progression (according to RECIST v1.1; if progression occurs in the nasopharynx or neck while metastatic lesions remain well controlled, radiotherapy to the nasopharynx and neck will be given, after which immunotherapy maintenance may continue until further progression), unacceptable toxicity, withdrawal of patient consent, or completion of a cumulative 2 years of treatment.
Overall survival
the time from the date of treatment initiation to the date of death due to any cause.
Progression free-survival
the time from the date of treatment initiation to the first objectively documented disease progression, or death from any cause, whichever occurs first.
Locoregional progression-free survival
the time from the date of treatment initiation to the occurrence of a locoregional progression
Distant progression-free survival
the time from the date of treatment initiation to the occurrence of a distant progression.
Incidence of toxicity
Assessed using CTCAE v5.0
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