An Exploratory Study of Fecal Microbiota Transplantation (FMT) Combined With Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- The incidence of serious adverse events (SAEs)
研究概览
简要总结
This research protocol outlines an exploratory study on the combination of early-life fecal microbiota transplantation (yFMT) with immunotherapy and chemotherapy in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). The single-center, single-arm study aims to assess the safety of yFMT in conjunction with immunotherapy and chemotherapy, with a secondary focus on exploring its efficacy and impact on the patients' immune microenvironment. The study will enroll 10 patients aged 18-75 who have progressed after first-line chemotherapy and targeted therapy. The intervention involves six sessions of yFMT every two weeks, alongside PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy. The primary endpoints are the incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and intervention adjustments due to adverse events, while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). The study is expected to last two years from initiation to data analysis completion, and it will be conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.
详细描述
The research protocol for the study titled "Exploratory Study of Early Life Fecal Microbiota Transplantation (yFMT) Combined with Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)" is designed to investigate a novel treatment approach for patients with MSS mCRC, a group that typically does not respond well to immunotherapy. The study is being conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.
Objectives:
Primary Objective: To evaluate the safety of combining yFMT with immunotherapy (PD-1 inhibitor) and chemotherapy (FOLFIRI) in patients with MSS mCRC.
Secondary Objectives: To explore the efficacy of the combined treatment in terms of progression-free survival (PFS), objective response rate (ORR), and overall survival (OS), as well as to assess the impact of yFMT on the patients' immune microenvironment and its potential synergistic effects with immunotherapy and chemotherapy.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Histologically or cytologically confirmed diagnosis of MSS mCRC
- •Experienced disease progression after first-line chemotherapy and targeted therapy
- •ECOG performance status of 0-1
排除标准
- •History of FMT
- •Severe organ dysfunction (heart, lung, liver, kidney)
- •Other malignancies, psychiatric disorders, pregnancy or lactation
- •Unable to provide informed consent
结局指标
主要结局
The incidence of serious adverse events (SAEs)
时间窗: From the initiation of yFMT treatment to the completion of follow-up
The proportion of patients experiencing serious adverse events (Grade ≥3 per CTCAE v5.0) during the treatment and follow-up period, including events related to yFMT, immunotherapy, or chemotherapy that result in death, life-threatening conditions, hospitalization, or persistent disability.
treatment-related adverse events (TRAEs)
时间窗: From the initiation of yFMT treatment to the completion of follow-up
The incidence of adverse events assessed as related to the study intervention (yFMT, PD-1 inhibitor, or FOLFIRI regimen) by the investigator, graded according to CTCAE v5.0, occurring from treatment initiation through the follow-up period.
the rate of intervention adjustments due to adverse events
时间窗: From the initiation of yFMT treatment to the completion of follow-up
The proportion of patients requiring dose reduction, treatment interruption, or discontinuation of yFMT, immunotherapy, or chemotherapy due to treatment-related adverse events, documented with reasons and duration of adjustments.
次要结局
- PFS(From treatment initiation to radiographic disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.)
- ORR(Objective response will be assessed every 6-8 weeks from the initiation of yFMT treatment until disease progression, death, or completion of 12-month study period (3-month treatment + 9-month follow-up), whichever occurs first.)
- OS(From treatment initiation until death (any cause) or last known alive date, up to 12 months.)
研究者
Qingqi Hong
Chief Physician
The First Affiliated Hospital of Xiamen University