An Open-Label, Multi-center, Phase 2 Study of Switch Maintenance With TAS-102 Plus Bevacizumab Following Oxaliplatin or Irinotecan-Based Fluoropyrimidine-Containing Induction Chemotherapy in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Length of Progression-Free Survival
研究概览
简要总结
Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
详细描述
Study Drug:
TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab
Dosing Details:
Starting dose of TAS-102 is 35 mg/m2 administered orally twice daily, after meals, for 5 days a week with 2 days rest for 14 days, followed by 14 days rest (1 treatment cycle).
Bevacizumab 5 mg/kg intravenously every 14 days. The treatment cycle repeats every 28 days. Patients may take TAS-102 plus bevacizumab until they exhibit progression of disease, withdraw consent, or experience unacceptable toxicity.This is a single arm study. All patients receive the same study 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
干预措施: TAS-102 (Drug)
TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Length of Progression-Free Survival
时间窗: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.
Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.
次要结局
未报告次要终点