A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- disease control rate according to the RECIST v1.1
研究概览
简要总结
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic, or recurrent AGC
- •Previous use of fluoropyrimidine as palliative chemotherapy. Concurrent use of platinum is permitted. Patient with recurred disease within 6 months after the end of adjuvant therapy can participate to this trial.
- •Documented HER2 expression status.
- •Radiologically proven progression of disease.
- •Age > 20 years
- •ECOG PS 0 - 2
- •Life expectancy more than 3 months
- •Adequate organ function for treatment including liver, kidney and bone marrow (absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 100,000/ul, AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement, Total serum bilirubin ≤ 2.0 mg/dL)
- •Written informed consent
排除标准
- •Prior administration of taxane or anthracycline as palliative chemotherapy. If those agents were used as adjuvant or neoadjuvant aim, at least 6 months should be passed.
- •Uncontrolled medical comorbidities Congestive heart failure (NYHA class III or IV) Recent (within 6 months) unstable angina or myocardial infarct Clinically significant cardiac arrhythmia LVEF < 45% Liver cirrhosis (Child-Pugh class B or C) Interstitial pneumonia Psychiatric illness/social situations that would limit compliance with study requirements
- •Active CNS metastasis not controllable with radiation or steroid
- •Concurrent administration of systemic chemotherapy or radiotherapy. Palliative radiotherapy for pain control more than 2 weeks ago is acceptable.
- •Pregnant or lactating women.
- •Peripheral neuropathy G3~
- •Metachronous malignancy other than adequately treated CIN of uterine cervix, basal cell or squamous cell carcinoma of the skin.
研究组 & 干预措施
HER2 positive
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)
干预措施: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks (Other)
HER2 negative
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)
干预措施: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks (Other)
结局指标
主要结局
disease control rate according to the RECIST v1.1
时间窗: at 6~8 weeks later after the first evaluation
The primary outcome of the current study is the disease control according to the HER2 status. That is, the % of the patients who maintains at least stable disease by RECIST v1.1 at the time of the second tumor evaluation which will be taken at 6\~8 weeks later after the first evaluation. The comparison will be done by Pearsons's chi-square test.
次要结局
未报告次要终点