Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma (NCT07177443) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma
China456 participantsStarted 2025-09-25
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. Adequate bone marrow function:
✓. Normal hepatic/renal function:
✓. Normal results for:
Exclusion criteria
✕. Signed informed consent with willingness/compliance to follow study schedules for treatment, follow-up, and laboratory tests;
✕0. For women of childbearing potential: Agreement to use reliable contraception (e.g., condoms, prescribed oral contraceptives) from screening until 1 year post-treatment.
✕. Hepatitis B Virus (HBV) Infection:
✕. Hepatitis C Virus (HCV) Infection: Anti-HCV antibody-positive.
✕. HIV/AIDS: Anti-HIV antibody-positive or diagnosed with acquired immunodeficiency syndrome (AIDS).
What they're measuring
1
Event-free survival (EFS)
Timeframe: 3-year
2
Overall survival (OS)
Timeframe: 5-year
3
Incidence rate of all-grade vomiting
Timeframe: Through study completion, an average of 1 year
Trial details
NCT IDNCT07177443
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
✕. 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).