NCT07067268招募中2 期
A Multicenter, Randomized Controlled, Phase II Trail of Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA After Radiotherapy
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Histologically confirmed nasopharyngeal carcinoma;
- •Expected survival time ≥12 weeks;
- •ECOG performance status: 0-1;
- •Received definitive radiotherapy (± induction and/or concurrent chemotherapy);
- •Plasma EBV DNA >0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ;
- •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.
- •Signed informed consent with willingness to comply with the study protocol.
排除标准
- •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;
- •History of autoimmune diseases, except for the following conditions (eligible after evaluation):
- •Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;
- •Type I diabetes mellitus under stable insulin therapy with controlled blood glucose;
- •Previous or concurrent malignancies (except those cured and disease-free for >5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);
- •Positive pregnancy test in women of childbearing potential;
- •Concurrent medical conditions that may compromise patient enrollment or safety during the study;
- •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases;
- •Active psychiatric disorders or other mental conditions affecting informed consent comprehension;
- •Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+);
- •Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular/ventricular arrhythmias requiring clinical intervention;
- •Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric/neurological disorders, chronic diarrhea, ascites, pleural effusion);
- •Unwillingness to sign informed consent.
研究组 & 干预措施
Adjuvant therapy arm
Experimental
Tislelizumab combined with capecitabine therapy
干预措施: Adjuvant therapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years
Defined from date of randomization to date of first documentation of progression or death due to any cause
次要结局
- Overall survival(3 years)
- Toxicities(3 years)
研究者
研究点 (1)
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