NCT03792568Unknown不适用
ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Respone Rate(ORR)
研究概览
简要总结
This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;
排除标准
- •Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.
研究组 & 干预措施
ALK mutation
Experimental
干预措施: ALK Inhibitor (Other)
结局指标
主要结局
Objective Respone Rate(ORR)
时间窗: up to 36months
Evaluation of tumor burden based on RECIST criteria every 2 month.
次要结局
未报告次要终点
研究者
Zhan Wang
ALK inhibitor in Metastatuc Colorectal Cancer with ALK mutation.
Shanghai Changzheng Hospital
研究点 (1)
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