Nasopharyngeal Cancinoma (NPC)
Conditions
Keywords
Nasopharyngeal Carcinoma, EBV DNA, Tislelizumab, capecitabine, Adjuvant therapy
Brief summary
This study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy.
Interventions
DRUGAdjuvant therapy
Tislelizumab: 200 mg IV on day 1, every 3 weeks Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks Treatment duration: 8 cycles
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Histologically confirmed nasopharyngeal carcinoma; 3. Expected survival time ≥12 weeks; 4. ECOG performance status: 0-1; 5. Received definitive radiotherapy (± induction and/or concurrent chemotherapy); 6. Plasma EBV DNA \>0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ; 7. Adequate organ function meeting the following criteria: Hematological: a. Hemoglobin (HB) ≥90 g/L; b. Absolute neutrophil count (ANC) ≥1.0×10⁹/L; c. Platelet count (PLT) ≥80×10⁹/L; Biochemical: a. Total bilirubin (BIL) \<1.5× upper limit of normal (ULN); b. ALT and AST \<2.5×ULN; c. Serum creatinine (Cr) ≤ULN, and creatinine clearance rate ≥50 mL/min (calculated by Cockcroft-Gault formula); d. Normal myocardial enzymes and thyroid function; e. Normal cardiac function assessed by echocardiography. 8. Signed informed consent with willingness to comply with the study protocol.
Exclusion criteria
1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)； 2. Distant metastasis detected by pre-treatment clinical or imaging examinations; 3. History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine; 4. History of autoimmune diseases, except for the following conditions (eligible after evaluation): 1. Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy; 2. Type I diabetes mellitus under stable insulin therapy with controlled blood glucose; 5. Previous or concurrent malignancies (except those cured and disease-free for \>5 years, e.g., basal cell carcinoma, cervical carcinoma in situ); 6. Positive pregnancy test in women of childbearing potential; 7. Concurrent medical conditions that may compromise patient enrollment or safety during the study; 8. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases; 9. Active psychiatric disorders or other mental conditions affecting informed consent comprehension; 10. Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+); 11. Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular/ventricular arrhythmias requiring clinical intervention; 12. Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric/neurological disorders, chronic diarrhea, ascites, pleural effusion); 13. Unwillingness to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years | Defined from date of randomization to date of first documentation of progression or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | The time from enrollment to death due to any cause or censored at the date of last follow-up. |
| Toxicities | 3 years | Adverse effects (AE) are evaluated by CTCAE 4.0 |
Countries
China
Contacts
Primary ContactHongmei Ying
Backup ContactFangfang Kong
Outcome results
None listed