About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
Histologically confirmed nasopharyngeal carcinoma;
Expected survival time ≥12 weeks;
ECOG performance status: 0-1;
Disqualifiers
Histologically confirmed keratinizing squamous cell carcinoma (WHO I);
Distant metastasis detected by pre-treatment clinical or imaging examinations;
History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;
Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;
Trial design
Parallel
Treatments tested in this trial
Adjuvant therapy
DrugTislelizumab: 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
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival
Defined from date of randomization to date of first documentation of progression or death due to any cause
Secondary outcomes
Overall survival
The time from enrollment to death due to any cause or censored at the date of last follow-up.
Toxicities
Adverse effects (AE) are evaluated by CTCAE 4.0
Sponsors and contacts
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