Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Intracranial progression-free survival
研究概览
简要总结
This study is a multicenter, randomized, prospective Phase III study to evaluate the efficacy and safety of anlotinib plus whole-brain radiotherapy (WBRT) compared with WBRT alone in small cell lung cancer (SCLC) patients with brain metastases. Additionally, by investigating the association between changes in circulating tumor cell (CTC) levels in peripheral blood and treatment response to the combination of targeted therapy and radiotherapy, we aim to identify a patient subgroup most likely to benefit from this regimen, as well as potential biomarkers predictive of treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Small cell lung cancer confirmed by pathology, with brain metastases diagnosed either at initial presentation or during treatment, and measurable disease according to RECIST criteria.
- •The expected survival time is more than 3 months.
- •Intracranial metastases ≤
- •Adequate organ and bone marrow function.
- •Women of childbearing potential must agree to use effective contraception during the study and for 6 months after its completion.
排除标准
- •Patients who have used antiangiogenic drugs within the previous 1 month.
- •Non-small cell lung cancer (including combined small cell carcinoma).
- •Small cell lung cancer with hilar invasion or hemoptysis.
- •Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage.
- •An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.
- •Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.
- •Patients with life-threatening conditions of other severe and/or uncontrolled diseases.
- •History of prior brain radiotherapy.
研究组 & 干预措施
Anlotinib+WBRT
Oral Anlotinib plus whole-brain radiotherapy
干预措施: Anlotinib (Drug)
Anlotinib+WBRT
Oral Anlotinib plus whole-brain radiotherapy
干预措施: Whole-brain Radiotherapy (Radiation)
Control WBRT
Only whole-brain radiotherapy
干预措施: Whole-brain Radiotherapy (Radiation)
结局指标
主要结局
Intracranial progression-free survival
时间窗: 1 year
Time from enrollment to intracranial tumor progression or death
次要结局
- Intracranial objective response rate (ORR) and disease control rate (DCR)(1 year)
- Duration of intracranial response (DOR)(1 year)
- Overall Survival (OS)(2 year)
- CTCs level(1 year)