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Recruiting Phase 2 NCT07067268

Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy

Trial Parameters

Condition Nasopharyngeal Cancinoma (NPC)
Sponsor Fudan University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 76
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-14
Completion 2026-09
Interventions
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.

Eligibility Criteria

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 keratiniz

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