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Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

Induction Chemotherapy Combined With Serplulimab Induction/Maintenance Therapy and Omission of Concurrent Chemotherapy in Locally Advanced Nasopharyngeal Carcinoma (UNION-NPC-001): A Multicenter, Open-Label, Randomized, Controlled, Phase III, Non-Inferiority Clinical Trial

NCT07177443•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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).

Detailed 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) * incidence of treatment-induced vomiting Secondary study endpoints * 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. * Incidence rate of investigator-reported adverse events (AEs) ⑤ Incidence rate of patient-reported AEs

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age at diagnosis: 18-65 years;
•2. Pathologically confirmed treatment-naïve nasopharyngeal carcinoma of "non-keratinizing type (WHO classification)";
•3. 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);
•4. ECOG performance status: 0-1;
•5. Post-induction therapy requirements:
•Radiological assessment showing ≥50% tumor regression (RECIST 1.1) Undetectable plasma EBV DNA levels;
•6. Adequate bone marrow function:
•White blood cell count \>4×10⁹/L Hemoglobin \>90 g/L Platelet count \>100×10⁹/L;
•7. 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;
+6 more criteria

Exclusion Criteria

•1. 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).
•2. Hepatitis C Virus (HCV) Infection: Anti-HCV antibody-positive.
•3. HIV/AIDS: Anti-HIV antibody-positive or diagnosed with acquired immunodeficiency syndrome (AIDS).
•4. 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.
•5. 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).
•6. Interstitial Lung Disease (ILD):
•History of ILD or pneumonitis requiring oral/IV steroids within the past year.
+15 more criteria

Locations (1)

Wuhan Union Hospital

Wuhan, Hubei, China

Key Dates

Start Date

September 25, 2025

Primary Completion Date

December 31, 2031

Completion Date

December 31, 2031

Last Updated

September 17, 2025

Enrollment

456

ESTIMATED participants

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Interventions

Radiotherapy

RADIATION

Serplulimab

DRUG

Cisplatin

DRUG

Contacts

Chao Wan

CONTACT

+86 18062775069 wanc@hust.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

Inclusion Criteria

Exclusion Criteria

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