An Open Label Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients With Malignancies Not Responding to Cancer Immunotherapy (CI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in the intestinal microbiome community
研究概览
简要总结
The intestinal microbiome forms a symbiotic relationship with the human host and continuously interacts with its immune system. Specific compositions of the intestinal microbiome in patients with cancer have been linked to the response to therapy with cancer immunotherapies (CI), such as immune checkpoint inhibitors (ICIs). The investigators hypothesize that fecal microbiota transplantation (FMT) from patients being responsive to ICI therapy (FMT-Donor) can modulate the intestinal microbiome of patients with CI-refractory malignancies (FMT-Recipients) and render them into responders. Successful proof-of-concept studies showed that reversion from an ICI non-responsive to a responsive disease is indeed possible in melanoma patients after FMT. This trial expands the FMT intervention to patients with any malignancy treated with cancer immunotherapy as a standard of care, to demonstrate the feasibility of this FMT approach as a novel option in cancer therapy.
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 —（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
FMT-Recipients
FMT-Recipients are patients with stage IV cancer, who have not sufficiently responded (stable disease or non-response) after at least 1 full cycle of CI. These patients will undergo the FMT procedure after the colon cleansing performed per routine treatment protocols at the Departement of Gastroenterology at the University Hospital of Zürich.
The stool is donated by FMT-Donors, which are patients with any solid cancer stage III or IV cancers, who received any ICI-Therapy and have experienced a durable partial or complete response.
FMT infusate will be administered via colonoscopy.
干预措施: Fecal Microbiota Transplantation (FMT) (Biological)
结局指标
主要结局
Change in the intestinal microbiome community
时间窗: up to 24 weeks
Mean change from baseline of bacterial species compared with 24 weeks post fecal microbiota transplantation (FMT).
次要结局
- CI response rate upon microbiome change(up to 24 weeks)
- Adverse Events Related to Study Intervention(up to 24 weeks)
- Objective Response Rate(up to 24 weeks)
- Progression-Free Survival(up to 24 weeks)
- Overall Survival(up to 24 weeks)
- Correlation between specific immune cell presence in blood/colon tissue and therapy response(up to 24 weeks)
- Quality of life based on the questionnaire(up to 24 weeks)
研究者
Michael Scharl
Prof. Dr. med.
University of Zurich