NCT03486379已完成不适用
FOLFIRI as a Second-line Therapy in Patients With Docetaxel-pretreated Gastric Cancer
IRCCS Cancer Referral Center of Basilicata0 个研究点目标入组 26 人开始时间: 2016年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 主要终点
- response rate (confirmed complete and partial response).
研究概览
简要总结
The aim of this study is to investigate the activity of Folfiri as Third line of treatment in mGC progressed after ramuciramb-based second line.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed, ramucirumab pretreated metastatic gastric cancer who received
- •Eastern Cooperative Oncology Group performance status ≤2 (ECOG PS)
- •aged > 18 years
- •neutrophil count ≥1500/μl
- •platelet count ≥100 000/μl),
- •renal (serum creatinine ≤1.5 mg/dl)
- •liver (serum bilirubin ≤2 mg/dL) functions
- •normal cardiac function,
- •absence of second primary tumor other than non-melanoma skin cancer
- •no concurrent uncontrolled medical illness.
排除标准
- •Eastern Cooperative Oncology Group performance status >2 (ECOG PS)
- •No prior treatment with ramucirumab
- •operable metastatic disease were excluded from the study
- •severe cardiac dysfunction, congestive heart failure or a recent myocardial infarction
- •uncontrolled sites of infection.
结局指标
主要结局
response rate (confirmed complete and partial response).
时间窗: From date of enrollment to best radiological evaluation, up to 12 months
rate of patients with complete or partial response
次要结局
- Progression free survival(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Overall survival(From date of enrollment until the date of death from any cause, whichever came first, assessed up to 12 months)
- Toxicity(From date to start therapy up to 12 months)
研究者
Giandomenico Roviello
MS, PhD
IRCCS Cancer Referral Center of Basilicata
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