jRCTs041210057招募中不适用
Investigation for the effects of synbiotics on the tumor microenvironment of colon cancer (NUSSG-01study) (Nagoya University Synbiotics Study Group-01 study (NUSSG-01study))
未提供0 个研究点目标入组 160 人开始时间: 2021年10月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 主要终点
- PD-L1 expression
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 90age old not（—）
- 性别
- All
入选标准
- •Patients who are scheduled to undergo curative resection for primary colorectal cancer. Both patients undergoing upfront surgery without preoperative chemotherapy (Upfront group) and patients undergoing surgery after preoperative chemotherapy (Preoperative chemotherapy group) are going to be included.
- •Patients who are diagnosed as having a primary colorectal cancer by biopsy.
- •Patients who are scheduled to undergo open, laparoscopic, or robotic surgery for colon cancer.
- •Patients with distant metastasis or unresectable cancer will also be included.
- •Patients who can intake synbiotics.
- •Patients who agree to buy synbiotics at own expense.
- •Patients who agreed to participate this study.
排除标准
- •Patients who are required to undergo emergent surgery.
- •Additional resection after endoscopic resection
- •Previous or scheduled radiotherapy for the abdomen
- •Any systemic chemotherapy within 6 months
- •Severe mental disorder
结局指标
主要结局
PD-L1 expression
The expression of PD-L1 as an immune response factor determined by immunohistochemistry between synbiotics and non-synbiotics group.
Counts of intraepithelial lymphocytes
The counts of intraepithelial lymphocytes as an immune response factor determined by immunohistochemistry between synbiotics and non-synbiotics group.
Inflammation-associated factors
The expressions of inflammation-associated factors determined by immunohistochemistry between synbiotics and non-synbiotics group.
Anti-tumor factors
The expressions of anti-tumor factors determined by immunohistochemistry between synbiotics and non-synbiotics group.
Tumor proliferation factors
The expressions of tumor proliferation factors determined by immunohistochemistry between synbiotics and non-synbiotics group.
次要结局
- Incidence of adverse events and completion rate of chemotherapy
- Three-year recurrence free survival after surgery(Three-year)
- Anti-tumorous effects of synbiotics
- Improvement of intestinal microenvironment
- Evaluation of occult-bacterial translocation
研究者
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