NCT04021589已完成2 期
A Study of Chemotherapy With WeiLeShu Versus Chemotherapy Alone in Patients With Metastatic Colorectal Cancer
Zhejiang University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
A total of 50 patients with metastatic colorectal cancer will be enrolled in the study. The patients were randomly divided into the WLS-intervention group and the control group. The two groups of patients were given the most appropriate medication according to the specific conditions of the disease. Patients in the intervention group received additional oral administration of Weileshu, a probiotics product (Tongchuang Biotechnology).
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
- •At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of colorectal cancer
- •Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation Non-pregnant women of childbearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age) ECOG status ≤ 1 at screening
排除标准
- 未提供
研究组 & 干预措施
WLS-intervention group
Experimental
chemotherapy + WLS
干预措施: Weileshu (Drug)
WLS-intervention group
Experimental
chemotherapy + WLS
干预措施: Chemotherapy (Drug)
the control group
Active Comparator
chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
progression free survival
时间窗: up to approximately half a year
time from randomization to progression
次要结局
- overall survival(up to approximately two years)
研究者
Weijia Fang, MD
director
Zhejiang University
研究点 (1)
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