This phase III trial aims to evaluate the efficacy and safety of induction chemotherapy combined with serplulimab (induction/maintenance therapy) with omission of concurrent chemotherapy in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).
Age at diagnosis: 18-65 years;
Pathologically confirmed treatment-naïve nasopharyngeal carcinoma of "non-keratinizing type (WHO classification)";
Locoregionally advanced nasopharyngeal carcinoma staged per the 9th edition of the American Joint Committee on Cancer (AJCC) staging system: Stage II (T1-3N2), Stage III(T1-4N3 or T4N1-2);
ECOG performance status: 0-1;
Hepatitis C Virus (HCV) Infection: Anti-HCV antibody-positive.
HIV/AIDS: Anti-HIV antibody-positive or diagnosed with acquired immunodeficiency syndrome (AIDS).
Active Tuberculosis (TB): History of active TB within the past year (regardless of treatment status). Exception: Patients with adequately treated past TB (confirmed by standard anti-TB therapy) may be enrolled if >1 year since completion of treatment.
Active Autoimmune Diseases:Known or suspected autoimmune disorders (e.g., uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, or asthma requiring bronchodilators).
Parallel
Radiotherapy
RadiationFollowing induction therapy, eligible patients will receive radiotherapy alone or concurrent chemoradiotherapy per protocol. Photon or proton radiotherapy techniques were permitted. Prescribed doses were: Primary tumor and metastatic lymph nodes: 70 Gy/33 fractions High-risk lymphatic drainage areas: 60 Gy/33 fractions Low-risk regions: 54 Gy/33 fractions PTV dose specifications: GTVnx: 70 Gy GTVnd: 66-70 Gy (reducible to 63 Gy for suspicious small nodes) CTV1: 60-62 Gy CTV2: 54-56 Gy All treatments will employ simultaneous integrated boost (SIB) intensity-modulated radiotherapy delivered once daily, 5 fractions per week.
Serplulimab
DrugSerplulimab will be used in the induction phase for 3 cycles and the maintenance phase for 14 cycles.
Cisplatin
DrugOn days 64 and 85, patients will receive cisplatin chemotherapy at a dose of 100 mg/m² via intravenous infusion.
Event-free survival (EFS)
EFS is defined as the time from the date of randomization to the first occurrence of disease recurrence (locoregional or distant) or death from any cause, whichever comes first.
Overall survival (OS)
OS is defined as the time from the date of randomization until death from any cause.
Incidence of Hearing Loss (any grade)
Proportion of participants experiencing any grade of hearing loss, assessed by pure-tone audiometry, auditory brainstem response, and acoustic immittance.
Distant metastasis-free survival (DMFS)
Time from randomization to the first occurrence of distant metastasis or death from any cause.
Locoregional recurrence-free survival (LRFS)
LRFS is defined as the time from the date of randomization to the first histologically or radiologically confirmed locoregional recurrence or death from any cause.
Health-Related Quality of Life assessed by EORTC QLQ-C30
Changes in health-related quality of life from baseline (informed consent) until 60 months after radiotherapy completion, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), version 3.0. The QLQ-C30 includes functional scales (e.g., physical, role, emotional), global quality of life scale, and symptom scales (e.g., fatigue, pain, nausea/vomiting). Scores range from 0 to 100. For functional scales and global quality of life, a higher score represents a better level of functioning or well-being. For symptom scales, a higher score represents a greater severity of symptoms.
Head and Neck Cancer-Specific Symptoms assessed by EORTC QLQ-H&N35
Changes in head and neck cancer-specific symptoms and side effects from baseline (informed consent) until 60 months after radiotherapy completion, assessed using the EORTC Head and Neck Cancer Module (QLQ-H\&N35), version 1.0. The QLQ-H\&N35 assesses symptoms relevant to head and neck cancer patients (e.g., pain, swallowing, senses, speech, social eating). Scores range from 0 to 100. For all symptom scales, a higher score represents a greater severity of symptoms.
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