[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630347":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":31,"responsibleParty":37,"collaborators":31,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":31,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":31,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":31,"overallStatus":60,"whyStopped":31,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":31},{"fullName":5,"class":6},"The First Affiliated Hospital of Xiamen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"yFMT + PD-1 Inhibitor + FOLFIRI Group","EXPERIMENTAL","This study evaluates a combined intervention of young-donor fecal microbiota transplantation (yFMT), PD-1 inhibitor immunotherapy, and FOLFIRI chemotherapy for microsatellite stable metastatic colorectal cancer (MSS mCRC) patients. yFMT (6 sessions every 2 weeks via nasogastric tube or oral capsules) aims to modulate the gut microbiome and enhance immune response, administered concurrently with weight-based PD-1 inhibitor and FOLFIRI regimen (fluorouracil, leucovorin, irinotecan) synchronized every 2 weeks. This 3-month treatment period, followed by 9-month follow-up, tests the hypothesis that yFMT synergistically improves immunotherapy efficacy through microbiome alteration. Patients are closely monitored for adverse events with prompt management and regimen adjustments to ensure safety.",[13],"Drug: yFMT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","yFMT","This 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.",[9],[21,22],"FOLFIRI Regimen","PD-1 Inhibitor",[24],{"name":25,"affiliation":5,"role":26},"Qingqi Hong, MD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":25,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","15980809201",null,"hqqsums@aliyun.com",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Hongfei Huang","15159672193","1378498011@qq.com",{"type":26,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Qingqi Hong","Chief Physician","100630347","early-phase-1-using-healthy-gut-bacteria-to-boost-immune-treatment-for-advanced-bowel-cancer-100630347",false,"NCT07486492","Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer","An Exploratory Study of Fecal Microbiota Transplantation (FMT) Combined With Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of MSS mCRC\n* Experienced disease progression after first-line chemotherapy and targeted therapy\n* ECOG performance status of 0-1\n\nExclusion Criteria:\n\n* History of FMT\n* Severe organ dysfunction (heart, lung, liver, kidney)\n* Other malignancies, psychiatric disorders, pregnancy or lactation\n* Unable to provide informed consent","ALL","18 Years","75 Years",{"count":51,"type":52},10,"ESTIMATED","INTERVENTIONAL",[55],"EARLY_PHASE1","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.",[58,59],"Colorectal Cancer Metastatic","Fecal Microbiota Transplantation","NOT_YET_RECRUITING","2026-03-17",{"date":63,"type":64},"2026-03-20","ACTUAL",{"date":66,"type":52},"2026-03-31",{"date":68,"type":52},"2028-01-31",{"name":5,"class":6}]