NCT07738042尚未招募不适用
To Explore a Single-arm Phase II Study on Intestinal Microbiota Transplantation Combined With Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Rectal Cancer Under MSS/pMMR
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年7月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pathological Complete Response rate
研究概览
简要总结
To evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR/MSS type)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG PS 0-1
- •The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible
- •RAS/BRAF wild type, pMMR/MSS status
- •Patients of childbearing age need to take effective contraceptive measures.
- •Voluntarily sign the informed consent form
排除标准
- •dMMR/MSI-H type
- •Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);
- •Active autoimmune diseases, inflammatory bowel disease;
- •Active infection, immune deficiency, severe liver and kidney dysfunction;
- •Severe intestinal obstruction, perforation or requiring emergency surgery;
- •Pregnant or lactating women;
- •Contraindications related to FMT (such as recent use of high-dose immunosuppressants, severe neutropenia, etc.);
- •Other circumstances where participation in clinical trials is not suitable
结局指标
主要结局
Pathological Complete Response rate
时间窗: After surgery, an average of 1-2 weeks
次要结局
- Safety（Adverse reactions）(During the treatment period, up to 3 months)
- R0 resection rate(After surgery, an average of 1-2 weeks)
- sphincter-preserving rate(After surgery, an average of 1-2 weeks)
- Objective response rate(After the drug treatment is completed, an average of 1-2 weeks)
- Major Pathological Response(After surgery, an average of 1-2 weeks)
研究者
研究点 (1)
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