Anlotinib Hydrochloride Combined With Whole Brain Radiotherapy for the Treatment of Brain Metastases in Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intracranial progression-free survival
研究概览
简要总结
The objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer
详细描述
This was a single-center, single-arm trail. Enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. Patients with brain metastases at first visit or during treatment were treated with whole brain radiotherapy combined with anlotinib hydrochloride. Oral antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for 1 week after 2 weeks. After radiotherapy, antirotinib was continued until tumor progression. Efficacy and toxicity data were collected for evaluation and analysis.
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 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, completion of at least 4 cycles of first-line chemotherapy, and measurable disease according to RECIST criteria.
- •The expected survival time is more than 3 months.
- •Intracranial metastases ≤
- •Adequate organ and bone marrow function.
排除标准
- •Patients who have used antiangiogenic drugs within the previous 1 month.
- •Non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer).
- •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.
研究组 & 干预措施
Anlotinib hydrochloride
Subjects received antirotinib hydrochloride capsules, 1 capsule (12mg) once a day.
干预措施: Antirotinib hydrochloride (Drug)
结局指标
主要结局
Intracranial progression-free survival
时间窗: 6 months
Time from enrollment to intracranial tumor progression or death
次要结局
- Overall Survival(1 year)
- progression-free survival(6 months)