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About
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).
Full description
This multicenter phase III trial enrolls high-risk locally advanced nasopharyngeal carcinoma patients (AJCC 9th edition, Stage T1-3N2 [II] or T1-4N3/T4N1-2 [III]) who achieves ≥50% tumor regression (RECIST v1.1) and undetectable plasma EBV DNA after three cycles of GP induction chemotherapy (gemcitabine + cisplatin) combined with serplulimab. Eligible patients will be randomized to either:
Experimental arm: Radiotherapy alone followed by serplulimab maintenance, or Control arm: Cisplatin-based concurrent chemoradiotherapy (CCRT) followed by serplulimab maintenance.
Primary study endpoint
3-year event-free survival (EFS)
5-year overall survival (OS)
3-year distant metastasis-free survival (DMFS)
3-year locoregional recurrence-free survival (LRFS)
Quality of life (QoL) assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 v3.0) and its head-and-neck cancer module (EORTC QLQ-H&N35 v1.0), both validated Chinese versions.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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;
Post-induction therapy requirements:
Radiological assessment showing ≥50% tumor regression (RECIST 1.1) Undetectable plasma EBV DNA levels;
Adequate bone marrow function:
White blood cell count >4×10⁹/L Hemoglobin >90 g/L Platelet count >100×10⁹/L;
Normal hepatic/renal function:
Total bilirubin ≤1.5×upper limit of normal (ULN) AST/ALT ≤2.5×ULN Alkaline phosphatase ≤2.5×ULN Creatinine clearance ≥60 mL/min;
Normal results for:
Thyroid function tests Amylase and lipase Pituitary function Inflammatory/infection markers Cardiac enzymes Electrocardiogram
Additional requirements:
Pulmonary function tests for smokers >50 years Cardiac ultrasound + myocardial function tests for patients with ECG abnormalities or cardiovascular history (unless meeting exclusion criterion (8));
Signed informed consent with willingness/compliance to follow study schedules for treatment, follow-up, and laboratory tests;
For women of childbearing potential: Agreement to use reliable contraception (e.g., condoms, prescribed oral contraceptives) from screening until 1 year post-treatment.
Exclusion criteria
Hepatitis B Virus (HBV) Infection:
HBsAg-positive with HBV DNA >1×10³ copies/mL (patients with controlled viremia [<1×10³ copies/mL] after antiviral therapy are eligible).
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).
Exceptions:
Type 1 diabetes mellitus Hypothyroidism managed with hormone replacement Skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia).
Interstitial Lung Disease (ILD):
History of ILD or pneumonitis requiring oral/IV steroids within the past year.
Immunosuppressive Therapy:
Chronic systemic corticosteroids (≥10 mg prednisone equivalent/day) or other immunosuppressants within 4 weeks prior to enrollment. Inhaled/topical steroids are permitted.
Uncontrolled Cardiac Disease: Heart failure (NYHA class ≥2), Unstable angina, Myocardial infarction within the past year, Clinically significant arrhythmias requiring treatment.
Pregnancy/Lactation: Pregnant or breastfeeding women (urine/blood pregnancy test required for women of childbearing potential).
Concurrent Malignancies:
History of other malignancies except:
Adequately treated non-melanoma skin cancer, Carcinoma in situ of the cervix, Papillary thyroid carcinoma.
Hypersensitivity: Known allergy to any component of the study drugs or excipients.
Active Infections:
Systemic infections requiring treatment within 1 week prior to enrollment.
Live Vaccines:
Administration of live vaccines within 30 days before the first immunotherapy dose.
Organ Transplantation: History of allogeneic organ transplantation.
Other High-Risk Conditions:
Any condition that may compromise patient safety or compliance per investigator assessment (e.g., severe psychiatric disorders, life-threatening comorbidities, or social/familial risk factors).
Primary purpose
Allocation
Interventional model
Masking
456 participants in 2 patient groups
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Central trial contact
Chao Wan
Data sourced from clinicaltrials.gov
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