Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed diagnosis of MSS mCRC
Experienced disease progression after first-line chemotherapy and targeted therapy
ECOG performance status of 0-1
Disqualifiers
History of FMT
Severe organ dysfunction (heart, lung, liver, kidney)
Other malignancies, psychiatric disorders, pregnancy or lactation
Unable to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
yFMT
DrugThis study evaluates a triple-combination therapy for MSS mCRC comprising: (1) yFMT (6 biweekly sessions via nasogastric tube or oral capsules using young-donor fecal microbiota to modulate gut microbiome); (2) weight-based PD-1 inhibitor immunotherapy; and (3) FOLFIRI chemotherapy (fluorouracil, leucovorin, irinotecan) synchronized biweekly with yFMT. The 3-month treatment period tests the hypothesis that yFMT enhances immunotherapy efficacy through microbiome-mediated immune modulation, followed by 9-month follow-up. Safety monitoring includes prompt adverse event management and regimen adjustments as needed.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: yFMT + PD-1 Inhibitor + FOLFIRI GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of serious adverse events (SAEs)
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.
Time frame
From the initiation of yFMT treatment to the completion of follow-up2
treatment-related adverse events (TRAEs)
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.
Time frame
From the initiation of yFMT treatment to the completion of follow-up3
the rate of intervention adjustments due to adverse events
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.
Time frame
From the initiation of yFMT treatment to the completion of follow-upSecondary outcomes
1
PFS
Progression-free survival, defined as the time from treatment initiation to radiographic disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Time frame
From treatment initiation to radiographic disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.2
ORR
Objective response rate, defined as the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1 criteria.
Time frame
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.3
OS
Overall survival, defined as the time from treatment initiation to death from any cause.
Time frame
From treatment initiation until death (any cause) or last known alive date, up to 12 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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