NCT04782089Unknown不适用
A Phase II, Open, Single-center Study of PD-1 Antibody and PARP Inhibitor as Consolidation Treatment for Patients With Extensive Stage Small Cell Lung Cancer Who Have Not Progressed After First-line Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment
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
- •All subjects were required to sign the informed consent before starting the study;
- •Histologically documented Extensive stage small cell lung cancer；
- •ECOG PS 0~1 ；
- •18-75 years；
- •According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
- •.Life expectancy ≥ 3 months；
排除标准
- •Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
- •Active infection including tuberculosis, HIV, hepatitis B and C；
- •Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;
- •Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
- •Symptomatic brain metastasis and cancerous meningitis;
研究组 & 干预措施
Camrelizumab+Fluzoparib
Experimental
干预措施: Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Approximately 3 years
To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS
次要结局
未报告次要终点
研究者
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