NCT02072317Unknown2 期
Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced gastric cancer
详细描述
from the first cycle of treatment (day one) to two month after the last cycle
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •1.18~75 years old 2.Pathological diagnosis of gastric cancer or gastroesophageal junction adenocarcinoma 3.patient failed after The first line treatment of 5-Fu and platinum ,patient relapse half year after using 5 - Fu and platinum as Postoperative adjuvant chemotherapy 4.ECOG 0-1 5.At least one measurable objective tumor lesions 6.ANC≥1.5*109/L；PLT≥80*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤1.5ULN； Cr≤ULN；Ccr≥60ml/min 7.Expected survival period for 3 months or more
- •patients with voluntary participation, and sign the informed consent
排除标准
- •Recurrence after transfer have received taxol or docetaxel as first-line chemotherapy,If the adjuvant chemotherapy with paclitaxel,From the last chemotherapy for 6 months or less
- •With uncontrollable large pleural or peritoneal effusion
- •In the near future has a history of myocardial infarction (3 months)
- •Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas;
- •With brain metastasis
- •Severe uncontrolled medical disease or acute infection
- •Pregnancy or breast-feeding women
- •Has a long history of chronic diarrhea, or now complete intestinal obstruction patients
研究组 & 干预措施
Paclitaxel plus raltitrexed
Experimental
taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
干预措施: taxel plus raltitrexed (Drug)
taxol
Active Comparator
taxol 135 mg/m2, every three weeks for a cycle
干预措施: taxol (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Since the date of random to disease progression or any cause of death，the average time is 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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