Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free survival (intracranial lesions)
研究概览
简要总结
Brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are important approaches to the treatment of brain metastases from NSCLC. Known to us, epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC, especially for EGFR mutation patients. However, due to the lower concentration of tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It is a challenge whether the further dose escalation of Icotinib will enhance its concentration in cerebrospinal fluid and thereby improve its therapeutic effect. Here the investigators examine the therapeutic effect and side-effect of double dose of Icitinib in treating patients with brain metastases from NSCLC who have suffered from the failure of conventional dose 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytologic diagnosis of NSCLC
- •Patients with disease progression after local treatment(WBRT and/or SRS) combined with Icotinib treatment.
- •Patients with EGFR mutation or the lesions that remains stable for more than 3 months after local treatment(WBRT and/or SRS) combined with Icotinib treatment.
- •ECOG performance status 0-2
- •Doctors consider the patients will not benefit from local treatment(WBRT and/or SRS)
- •Expected survival of greater than 3 months
- •Age: 18-75 years
- •The patients with key organs maintenance of basic function: Hemoglobin ≥ 9g/dL, White Blood Cell ≥ 3×109/L, Neutrophil count ≥ 1.5×109/L, platelets ≥ 80×109/L, total bilirubin < 1.5 times of the upper normal values, Alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 of the upper normal values, the serum creatinine < 1.5 times of the upper normal values
- •Signed informed consent document on file.
排除标准
- •Brain metastasis without local treatment before
- •Patients without the treatment of Icotinib before or the therapeutic time less than 3 months
- •More than 3 extracranial organs have metastatic lesions
- •The patient with other type malignant tumors before
- •The patient with fertility capacity, but without contraceptive application
研究组 & 干预措施
Icotinib,Brain metastases
干预措施: Icotinib (Drug)
结局指标
主要结局
Progression-free survival (intracranial lesions)
时间窗: 2 years
次要结局
- Partial response rate of extracranial lesion(2 years)
- Overall survival(3 years)
- Partial response rate of intracranial lesions(2 years)
- Health-related quality of life quality(2 years)
- number of adverse events such as skin rash,diarrhea ,abnormal liver function and so on(2 years)