Status:
NOT_YET_RECRUITING
Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Locally Advanced Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 w...
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 regressio...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT07177443
Start Date
September 25 2025
End Date
December 31 2031
Last Update
September 17 2025
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022