NCT07198217招募中2 期
Real World Study of Platinum Containing Dual Drug Chemotherapy Followed by Large Fractionated Radiotherapy Combined withTislelizumab in Stage IIIB/C-IV Non-small Cell Lung Cancer Patient
Zibo Municipal Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- One-year PFS rate
研究概览
简要总结
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.
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
- •Age 18-75 years old, gender is not limited;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
- •Tumor histology or hematology confirms no EGFR mutations and no mutations or positive driver genes for ALK, BRAF, ROS1, RET, MET, etc or Targeted drug therapy leads to drug resistance progression
排除标准
- •Patients with uncontrolled autoimmune diseases;
- •Patients who have experienced autoimmune reactions within the past 6 months and whose conditions have not improved or are unstable after corresponding treatments, such as pneumonia, thyroiditis, myocarditis, etc. that have not stabilized after treatment;
- •Patients who have previously received systemic chemotherapy, or adjuvant or neoadjuvant therapy, and the time from the last treatment to recurrence is less than 3 months;
- •Patients with known allergies or contraindications to the study drug or its excipients;
- •Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
- •Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial;
- •Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
treatment arm
Experimental
干预措施: SBRT combined with Tislelizumab followed by Tislelizumab (Drug)
结局指标
主要结局
One-year PFS rate
时间窗: Up to approximately 24 months
The proportion of patients who survived for more than one year after treatment without disease progression
次要结局
- Progression-Free Survival (PFS)(Up to approximately 30 months)
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Overall survival (OS)(Up to ~48 months)
- Disease Control Rate (DCR)(Up to ~24 months)
- Adverse events(Through study completion, an average of 2 year)
研究者
研究点 (1)
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