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.
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
Eligibility
Sex: ALLMin age: 18 Years
Medical Language ↔ Plain English
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.
Locations (1)
Fudan Universtiy Shanghai Cancer Centre
Shanghai, China, China
RECRUITING
Outcomes
Primary Outcomes
Progression-free survival
Defined from date of randomization to date of first documentation of progression or death due to any cause
Time frame: 3 years
Secondary Outcomes
Overall survival
The time from enrollment to death due to any cause or censored at the date of last follow-up.