Re-irradiation is the most common clinical treatment for recurrent nasopharyngeal carcinoma; however, it is associated with severe complications which seriously affect patients' quality of life.
Exploring deferred salvage radiotherapy until nasopharyngeal or cervical progression after PD 1 plus GP chemotherapy and immunotherapy maintenance is of great significance for improving the long-term survival and quality of life of patients with unresectable locally recurrent NPC.
Thus, the investigators plan to conduct a multicenter, prospective, single-arm phase II clinical trial to evaluate the efficacy and safety of maintenance Immunotherapy with deferred salvage radiotherapy with an objective response to chemoimmunotherapy in patients with unresectable locally recurrent NPC .
Age 18-70 years, any gender.
primary tumour recurrent T classificationT2-T4, regional lymph nodes recurrent N classificationN0-N2, no distant metastasis (recurrent M0); overall recurrent stage II-III according to the American Joint Committee on Cancer Union for International Cancer Control 9th edition stage-classification system.
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).
known pre-existing radiation-induced complications, including soft tissue necrosis, brain injury, neck fibrosis, or other radiation-induced complications of grade 3 or above
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
Maintenance Immunotherapy With Deferred Salvage 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 is confined to the nasopharynx and/or neck without new metastatic lesions, salvage radiotherapy to these regions will be given, followed by continued immunotherapy maintenance 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 maintenance treatment initiation to the date of death due to any cause.
Progression free-survival
the time from the date of maintenance 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 maintenance treatment initiation to the occurrence of a locoregional progression
Distant progression-free survival
the time from the date of maintenance treatment initiation to the occurrence of a distant progression.
Incidence of acute and late toxicity
Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 6.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
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