Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer
Starting soon · Early Phase 1
Conditions studied: Colorectal Cancer Metastatic, Fecal Microbiota Transplantation
In brief
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.
Key facts
- Study ID
- NCT07486492
- Run by
- The First Affiliated Hospital of Xiamen University
- People needed
- 10
- Starts
- 2026-03-31
- Expected to finish
- 2028-01-31
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed diagnosis of MSS mCRC
- Experienced disease progression after first-line chemotherapy and targeted therapy
- ECOG performance status of 0-1
You may not qualify if…
- History of FMT
- Severe organ dysfunction (heart, lung, liver, kidney)
- Other malignancies, psychiatric disorders, pregnancy or lactation
- Unable to provide informed consent
Full record on ClinicalTrials.gov
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