NCT06056115招募中不适用
Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1 years PFS
研究概览
简要总结
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.
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
- 否
入选标准
- •Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
- •Patients with brain metastases confirmed by imaging;
- •Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
- •ECOG PS: 0-1;
- •Measurable target lesions outside the skull (as per RECIST 1.1);
- •Life expectancy greater than 3 months;
排除标准
- •Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
- •The patient had received systemic chemotherapy as advanced treatment;
- •Patients with EGFR mutation or ALK gene translocation;
- •The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
- •Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
研究组 & 干预措施
Tislelizumab Combined With Platinum-containing Drug Chemotherapy
Experimental
- Tislelizumab PD-1 inhibitor
- Platinum-containing drug chemotherapy
干预措施: Tislelizumab,Platinum (Drug)
结局指标
主要结局
1 years PFS
时间窗: up to 1year
the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first
次要结局
- The objective response rate (ORR)(Through study completion, an average of 12 months)
研究者
Jian SHI
Professor
Hebei Medical University Fourth Hospital
研究点 (1)
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