A Prospective, Single-Arm, Exploratory Study of SBRT Combined With Nimotuzumab and Sequential Tislelizumab for Oligoprogressive Distant Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR）
研究概览
简要总结
This study is a single-arm, open-label, prospective, and exploratory investigation aimed at examining the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 1.
- •Patients with recurrent/metastatic nasopharyngeal carcinoma who have previously received first-line treatment including anti-PD-1 immune checkpoint inhibitor therapy and failed, presenting with oligoprogression (1-5 metastatic lesions); 1.
- •Eligible to receive SBRT, Tislelizumab, and Nimotuzumab; 1.
- •No history of other malignant tumors; 1.
- •Male or female, aged 18-75 years; 1.
- •Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5 × ULN; 1.
- •Renal function: Creatinine clearance ≥ 80 mL/min; 1.
- •Hematological tests: Absolute neutrophil count (ANC) ≥ 2 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL; 1.
- •No severe dysfunction of heart, lung, and other vital organs; 1.
- •Performance Status (PS) score ≤
排除标准
- •Disagree to sign the informed consent form; 2.
- •Patients who cannot comply with regular follow-ups due to psychological, social, family, or geographical reasons; 2.
- •Receiving other experimental treatments as part of a clinical study (during the treatment period of the clinical study); 2.
- •Severe, uncontrolled infections or medical conditions; 2.
- •Major organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy or immunotherapy; 2.
- •Factors affecting drug administration, distribution, metabolism, or excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; 2.
- •Overexposure to glucocorticoids within 2 weeks before immunotherapy; 2.
- •Long-term use of immunosuppressive agents after organ transplantation.
研究组 & 干预措施
Experimental
SBRT combined with Nimotuzumab followed by Tislelizumab
干预措施: SBRT combined with Nimotuzumab followed by Tislelizumab (Drug)
结局指标
主要结局
Objective response rate (ORR）
时间窗: 6 months
To investigate the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.
次要结局
- Progression-free survival rate(6 months)
研究者
San-Gang Wu
Dr.
The First Affiliated Hospital of Xiamen University