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

Not Applicable

Recruiting

• Conditions: Nasopharyngeal Cancinoma (NPC)
• Interventions: Drug: Adjuvant therapy

• Registration Number: NCT07067268
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-14
• Status Verified: 2025-07
• Study First Submitted: 2025-07-05
• Study First Submitted QC: 2025-07-05
• Last Update Submitted: 2025-07-05
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-09
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant therapy arm	Adjuvant therapy	Tislelizumab combined with capecitabine therapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival	3 years	Defined from date of randomization to date of first documentation of progression or death due to any cause

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan Universtiy Shanghai Cancer Centre; 🇨🇳 Shanghai, China