[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559424":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":51,"studyPopulation":48,"armGroups":52,"interventions":59,"overallOfficials":65,"centralContacts":70,"locations":76,"responsibleParty":92,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":48,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":48,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":48,"overallStatus":78,"whyStopped":48,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Shenzhen Third People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","Time from the first dose of FMT capsules to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.","From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Overall Survival (OS)","Time from the first dose of FMT capsules to death from any cause.","From the first dose of FMT capsules to death from any cause, up to approximately 1 year",{"measure":19,"description":20,"timeFrame":21},"Objective Response Rate (ORR)","Proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1.","From the first dose of FMT capsules through approximately 1 year",{"measure":23,"description":24,"timeFrame":25},"Duration of Response (DOR)","For participants with a complete or partial response, time from the first documented response to radiographic disease progression or death from any cause, whichever occurs first.","From the first documented response to disease progression or death, up to approximately 1 year",{"measure":27,"description":28,"timeFrame":21},"Disease Control Rate (DCR)","Proportion of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1.",[30,34,37,40],{"measure":31,"description":32,"timeFrame":33},"Gut microbiome diversity by shotgun metagenomic sequencing","Longitudinal fecal samples will be analyzed by shotgun metagenomic sequencing to assess alpha diversity, beta diversity, and changes in overall gut microbial community structure.","Up to approximately 1 year",{"measure":35,"description":36,"timeFrame":33},"Gut microbiome taxonomic and functional profiling by shotgun metagenomic sequencing","Longitudinal fecal samples will be analyzed by shotgun metagenomic sequencing to characterize microbial taxonomic composition and functional pathways, and to evaluate treatment-associated changes over time.",{"measure":38,"description":39,"timeFrame":33},"Single-cell transcriptomics","Single-cell RNA sequencing will be used to characterize cell populations, cellular states, and treatment-associated transcriptional changes.",{"measure":41,"description":42,"timeFrame":33},"Plasma metabolomics","Longitudinal plasma samples will be analyzed by mass spectrometry-based metabolomic profiling to identify treatment-associated changes in metabolites and metabolic pathways.",{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":48,"timePerspective":48,"maskingInfo":49},"NA","SINGLE_GROUP","This is a prospective, single-center, open-label, single-arm phase 2 study. Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.","TREATMENT",null,{"masking":50,"maskingDescription":48,"whoMasked":48},"NONE","This is a prospective, single-center, single-arm clinical study evaluating the efficacy and safety of oral fecal microbiota transplantation (FMT) capsules in patients with advanced hepatocellular carcinoma (HCC) whose disease has progressed during immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) therapy.\n\nAfter enrollment, participants will continue the same ICI-TKI regimen according to its prescribed schedule. In addition, oral FMT capsules (300 mg per capsule) will be administered at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles. ICI-TKI therapy will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.\n\nThe primary endpoint is progression-free survival (PFS), defined as the time from the first dose of FMT capsules to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.\n\nSecondary endpoints include overall survival (OS), defined as the time from the first dose of FMT capsules to death from any cause; objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1; duration of response (DOR), defined for participants with CR or PR as the time from the first documented response to radiographic disease progression or death from any cause, whichever occurs first; and disease control rate (DCR), defined as the proportion of participants with CR, PR, or stable disease (SD) according to RECIST version 1.1.\n\nAdverse events will be evaluated and graded according to CTCAE version 5.0. Other assessments include protocol-specified imaging, laboratory tests, and quality-of-life measures.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy","EXPERIMENTAL","Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules (300 mg per capsule) at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.",[58],"Biological: Oral fecal microbiota transplantation capsules",[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":48},"BIOLOGICAL","Oral fecal microbiota transplantation capsules","Oral fecal microbiota transplantation capsules (300 mg per capsule) are administered at a dose of 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles. Participants continue their pre-enrollment ICI-TKI regimen during FMT treatment.",[54],[66],{"name":67,"affiliation":68,"role":69},"Yong Xu, Dr","Secretary of the Party Committee of the Shenzhen Third People's Hospital","PRINCIPAL_INVESTIGATOR",[71],{"name":72,"role":73,"phone":74,"phoneExt":48,"email":75},"Cineng Xu, Dr","CONTACT","13530871434","822265652@qq.com",[77],{"facility":5,"status":78,"city":79,"state":48,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Shenzhen","518112","China","CN",{"type":84,"coordinates":85},"Point",[86,87],114.0683,22.54554,{"lat":87,"lon":86},[90],{"name":72,"role":73,"phone":91,"phoneExt":48,"email":75},"+86 13530871434",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"SPONSOR_INVESTIGATOR","Xu Yong, MD","Secretary of the Party Committee & Principal Investigator",[97],{"name":98,"class":99},"Nanjing Xiershou Biotechnology Co., Ltd","UNKNOWN","100559424","phase-2-single-arm-clinical-trial-gut-microbiota-and-hcc-100559424",false,"NCT06563947","Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy","A Phase 2, Single-Arm Study of Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy","Inclusion Criteria:\n\n1. Age 18-75 years old, gender is not limited;\n2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;\n3. Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;\n4. Not suitable for local ablation or chemoembolization;\n5. Child-Pugh class A or B, with a score of ≤7;\n6. ≥ 1 measurable lesion (RECIST v1.1)\n7. ECOG PS 0-2\n\nExclusion Criteria:\n\n1. Use of antibiotics within 4 weeks prior enrollment;\n2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)\n3. Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n4. Female patients who are pregnant or breastfeeding;\n5. Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.\n6. Patients are currently undergoing clinical trials of other drugs;\n7. Patients are considered by the investigator to be unsuitable for inclusion.","ALL","18 Years","75 Years",{"count":111,"type":112},30,"ESTIMATED","INTERVENTIONAL",[115],"PHASE2","This prospective, single-center, single-arm phase 2 study evaluates the efficacy and safety of adding oral fecal microbiota transplantation (FMT) capsules to continued immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) therapy in adults with advanced hepatocellular carcinoma (HCC) whose disease has progressed during ICI-TKI therapy.",[118],"Advanced Hepatocellular Carcinoma","2026-09-06",{"date":121,"type":122},"2026-09-10","ACTUAL",{"date":124,"type":122},"2024-09-03",{"date":126,"type":112},"2027-11-20",{"name":94,"class":6},1]