Actively Recruiting
Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy
Led by Fudan University · Updated on 2025-07-16
76
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed nasopharyngeal carcinoma
- Expected survival time of at least 12 weeks
- ECOG performance status of 0 or 1
- Received definitive radiotherapy with or without induction or concurrent chemotherapy
- Detectable plasma EBV DNA within 1 week before to 4 weeks after radiotherapy completion
- Adequate organ function including hemoglobin ≥90 g/L, neutrophils ≥1.0x10^9/L, platelets ≥80x10^9/L
- Total bilirubin less than 1.5 times upper limit of normal
- ALT and AST less than 2.5 times upper limit of normal
- Serum creatinine at or below upper limit of normal and creatinine clearance ≥50 mL/min
- Normal myocardial enzymes and thyroid function
- Normal cardiac function by echocardiography
- Signed informed consent and willingness to comply with study protocol
You will not qualify if you...
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- Presence of distant metastasis before treatment
- Allergy to monoclonal antibodies, tislelizumab, or capecitabine
- History of autoimmune diseases except stable hypothyroidism on replacement therapy or controlled type I diabetes
- Previous or current malignancies except those cured and disease-free for over 5 years
- Positive pregnancy test in women of childbearing potential
- Medical conditions compromising enrollment or safety
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active lung diseases
- Active psychiatric disorders affecting consent understanding
- Uncontrolled active infections including tuberculosis, hepatitis B, hepatitis C, or HIV
- Significant heart diseases including NYHA class II or higher, recent heart attack, unstable angina, or arrhythmias requiring treatment
- Conditions affecting drug handling such as psychiatric or neurological disorders, chronic diarrhea, ascites, or pleural effusion
- Unwillingness to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan Universtiy Shanghai Cancer Centre
Shanghai, China, China, 200032
Actively Recruiting
Research Team
H
Hongmei Ying
CONTACT
F
Fangfang Kong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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