[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658130":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":41,"armGroups":46,"interventions":52,"overallOfficials":57,"centralContacts":63,"locations":72,"responsibleParty":89,"collaborators":41,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":41,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":41,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":117,"whyStopped":41,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Objective response rate （ORR）","To assess the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to Objective Response Rate （ORR）.","Every 9 weeks from the first dose of FMT administration until the first documented disease progression, death or study completion, up to approximately 1 year.",[14,17,21,25],{"measure":15,"description":16,"timeFrame":12},"Disease Control Rate （DCR）","To observe and evaluate the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for unresectable or metastatic HCC with respect to Disease Control Rate （DCR) determined by the radiologist per mRECIST v1.1 criteria.",{"measure":18,"description":19,"timeFrame":20},"Progression-Free Survival （PFS)","Time from the start of treatment to the first documented disease progression as determined by the radiologist per mRECIST\u002F RECIST v1.1 criteria or death from any cause.","From first study treatment until the first documented disease progression or death from any cause, whichever occurs first, up to approximately 1 year.",{"measure":22,"description":23,"timeFrame":24},"Overall Survival （OS）","To observe and evaluate the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to overall survival （OS).","Starting from the time of treatment until death from any cause assessed from the date of the first intervention up to 24 months.",{"measure":26,"description":27,"timeFrame":28},"Adverse events （AEs）","To observe and evaluate the safety of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to adverse events （AEs） AEs will be graded according to NCI-CTCAE V5.0 Safety assessments will be performed from baseline through 30 days （±7 days） after the last dose of study treatment","30 days",[30,34],{"measure":31,"description":32,"timeFrame":33},"Changes in patient gut microbiome composition following FMT","Changes in patient gut microbiome will be determined by analysis of gut bacterial composition in patient stool samples at baseline and post-FMT","At baseline （prior to the first FMT administration）, before QL1706 plus bevacizumab administration on Days 6,27, and 48, and after the third administration （approximately 9 weeks after FMT initiation）.",{"measure":35,"description":36,"timeFrame":37},"Multi-Omics prognosis biomarker Profiles","Changes from baseline in prespecified metabolomic and immune-related biomarkers measured using metabolomic analysis and immunological assays, respectively, and their associations with clinical and associated mechanisms.","At baseline （prior to the first FMT administration）, before QL1706 plus bevacizumab administration on Days 6,27, and 48, and after the third administration （approximately 9 weeks after FMT initiation).",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":41,"timePerspective":41,"maskingInfo":43},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":44,"maskingDescription":41,"whoMasked":41},"NONE","Iparomlimab and Tuvonralimab （QL1706）, constitute a bifunctional antibody target both programmed death-1 and cytotoxic T lymphocyte-associated protein-4.\n\nThe purpose of this pilot study is to assess the efficacy and safety of fecal microbiota transplantation （FMT） combined with QL1706 Plus Bevacizumab as first-line treatment for advanced HCC.\n\nThe primary objective is to test the efficacy of FMT combined with QL1706 Plus Bevacizumab, as measured by objective response rate （ORR）.\n\nThe secondary objectives are to assess and test the safety of FMT in combination with QL1706 Plus Bevacizumab as first-line treatment for advanced HCC as measured by Disease Control Rate （DCR）, Duration of Response（DoR), Progression-Free Survival （PFS）, Overall Survival （OS), and Adverse Events （AEs).\n\nFurthermore, this study aims to investigate multi-omics prognosis prediction biomarkers and their associated mechanisms.",[47],{"label":48,"type":49,"description":48,"interventionNames":50},"FMT combined with QL1706 plus Bevacizumab","EXPERIMENTAL",[51],"Drug: FMT combined with QL1706 plus Bevacizumab",[53],{"type":54,"name":48,"description":55,"armGroupLabels":56,"otherNames":41},"DRUG","Oral Fecal Microbiota Transplantation （FMT） capsules:\n\nFull-dose FMT (80-100g) will be administered on Days 0,28, and 49.\n\nIparomlimab and Tuvonralimab （QL1706）:\n\nQL1706 will be administered intravenously at a dose of 7.5 mg\u002Fkg, with the first administration on Day 7, followed by subsequent administrations on Days 28 and 49, thereafter every 21 days.\n\nBevacizumab:\n\nBevacizumab will be administered intravenously at a dose of 15 mg\u002Fkg body weight, with the first administration on Day 7, followed by subsequent administrations on Days 28 and 49, thereafter every 21 days.",[48],[58,61],{"name":59,"affiliation":5,"role":60},"Hao Jihui, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":62,"affiliation":5,"role":60},"Zhang Ningning, MD, PhD",[64,68],{"name":62,"role":65,"phone":66,"phoneExt":41,"email":67},"CONTACT","+8615822153931","mail4ningning@163.com",{"name":69,"role":65,"phone":70,"phoneExt":41,"email":71},"Liu Yue, PhD","+8615245104487","liuxiaotian116@163.com",[73],{"facility":5,"status":41,"city":74,"state":41,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Tianjin","300060","China","CN",{"type":79,"coordinates":80},"Point",[81,82],117.17667,39.14222,{"lat":82,"lon":81},[85,86,87],{"name":69,"role":65,"phone":70,"phoneExt":41,"email":71},{"name":59,"role":60,"phone":41,"phoneExt":41,"email":41},{"name":62,"role":88,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"type":90,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100658130","phase-2-fecal-microbiota-transplantation-with-ql1706-plus-bevacizumab-for-advanced-hcc-100658130",false,"NCT07847671","Fecal Microbiota Transplantation Combined With QL1706 Plus Bevacizumab for Advanced HCC","Fecal Microbiota Transplantation （FMT） Combined With QL1706 Plus Bevacizumab as First-line Treatment for Advanced HCC","Inclusion Criteria:\n\n* Age \\>18 years.\n* Confirmed imaging or histological diagnosis of unresectable HCC.\n* Treatment-naïve unresectable or metastatic HCC.\n* BCLC Stage C.\n* Child-Pugh A.\n* ECOG PS 0-1.\n\nExclusion Criteria:\n\n* Prior treatment with an immune checkpoint inhibitor, or prior systemic therapy for advanced HCC.\n* Histologic subtypes other than hepatocellular carcinoma, including fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular cholangiocarcinoma.\n* Active or prior autoimmune disease, immunodeficiency requiring systemic immunosuppressive therapy.\n* Clinically significant bleeding risk, coagulopathy, or untreated high-risk esophagogastric varices.\n* Any contraindication to fecal microbiota transplantation.\n* Uncontrolled intercurrent illness, including active infection, clinically significant cardiovascular disease, central nervous system metastases.\n* Pregnancy or breastfeeding.","ALL","18 Years","75 Years",{"count":102,"type":103},20,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","This is a prospective, single-center, single-arm Phase II pilot study designed to evaluate the efficacy and safety of FMT in combination with QL1706 and Bevacizumab as first-line treatment for advanced Hepatocellular carcinoma.",[109],"Advanced Hepatocellular Carcinoma (HCC)",[111,112,113,114,115,116],"Fecal Microbiota Transplantation","Advanced Hepatocellular Carcinoma","QL1706","Bevacizumab","Iparomlimab","Tuvonralimab","NOT_YET_RECRUITING","2026-10-05",{"date":120,"type":121},"2026-10-08","ACTUAL",{"date":123,"type":103},"2026-10-10",{"date":125,"type":103},"2031-10",{"name":5,"class":6},1]