Anlotinib Hydrochloride Therapy in Patients With Advanced Lung Cancer: A Real World Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world.
Subjects of the study: advanced Lung cancer.
Methods of the study:
This is a real world, prospective, Non-Interventional, Follow-up registration study.
Patients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle.
End point:
Primary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.
- •Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment.
- •Eastern Cooperative Oncology Group performance status of 0-2.
排除标准
- •Contraindication of anlotinib.
- •Pregnant or lactating women.
- •Other patients who can't enroll after investigator's assessment.
研究组 & 干预措施
experiment
The patients whose treatment strategy containing anlotinib.
干预措施: Anlotinib Hydrochloride (Drug)
结局指标
主要结局
PFS
时间窗: 1 year
progression-free survival
次要结局
- DCR(1 year)
- OS(1 year)
- ORR(1 year)