Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

NCT07177443 | Not Yet Recruiting Phase 3

• 1 other identifier: UNION-NPC-001
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Keywords

Cisplatin-based concurrent chemoradiotherapy; radiotherapy; Treatment De-escalation; locally advanced nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  3-year

• Overall survival (OS)

  OS is defined as the time from the date of randomization until death from any cause.

  5-year

• Incidence rate of all-grade vomiting

  Incidence rate of all-grade vomiting during treatment assessed by clinicians according to the Common Terminology Criteria for Adverse Events 5.0.

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Distant metastasis-free survival (DMFS)

  3-year

• Locoregional recurrence-free survival (LRFS)

  3-year

• Health-Related Quality of Life assessed by EORTC QLQ-C30

  From baseline (at informed consent) up to 60 months after radiotherapy completion.

• Head and Neck Cancer-Specific Symptoms assessed by EORTC QLQ-H&N35

  From baseline (informed consent) until 60 months after radiotherapy completion.

• Incidence rate of investigator-reported adverse events (AEs)

  3-year

Study Arms (2)

Experimental arm

EXPERIMENTAL

Radiotherapy

Radiation: Radiotherapy; Drug: Serplulimab

Control arm

ACTIVE COMPARATOR

Cisplatin-based concurrent chemoradiotherapy (CCRT)

Radiation: Radiotherapy; Drug: Serplulimab; Drug: Cisplatin

Interventions

Radiotherapy RADIATION

Following 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.

Control arm; Experimental arm

Serplulimab DRUG

Serplulimab will be used in the induction phase for 3 cycles and the maintenance phase for 14 cycles.

Control arm; Experimental arm

Cisplatin DRUG

On days 64 and 85, patients will receive cisplatin chemotherapy at a dose of 100 mg/m² via intravenous infusion.

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

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

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Interventions

Radiotherapy; Cisplatin

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Chao Wan

CONTACT

+86 18062775069; wanc@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 17, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)