The Therapeutic Effect of Crizotinib in Patients With ALK-rearrangement-negative But High Expression of ALK Phosphorylation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Clinical efficacy
研究概览
简要总结
Patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib .
详细描述
Some patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib 250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 80 years
- •Histologically or cytologically confirmed stage IIIB or IV ALK-negative NSCLC by NGS
- •Disease staging determined according to the International Association for the Study of Lung Cancer 8th edition TNM staging system
- •All measurable Response Evaluation Criteria in Solid Tumors (RECIST) target lesions
- •Treatment failure at the end of the most recent treatment episode
- •World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Consent of patients for participation in this study
- •Complete clinical data
- •High ALK phosphorylation level
排除标准
- •Patients with cognitive impairment, severe psychiatric diseases, or other disorders likely to impact informed consent
- •Patients with uncontrolled systemic disease
- •Patients with other malignant tumors
研究组 & 干预措施
Experimental
Patients with positive ALK phosphorylation expression were treated with crizotinib 250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib treatment. Treatment with crizotinib continued until the patient experienced unacceptable toxicity, was pregnant, or started new cancer therapy.
干预措施: crizotinib for rearrangement-negative, high phosphorylated ALK patients (Drug)
结局指标
主要结局
Clinical efficacy
时间窗: SIx months
The clinical efficacy was evaluated according to the RECIST 1.1 guidelines\[5\], including PD, stable disease (SD), partial response (PR), and complete remission (CR), where the objective response rate (ORR) = (CR + PR) number of cases/total number of cases, and the disease control rate (DCR) = (CR + PR + SD) number/total number of cases.
次要结局
- The progression-free survival(3 years)
研究者
Xuemeng Li
Clinical Doctor
Harbin Medical University