[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658805":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":47,"studyPopulation":43,"armGroups":48,"interventions":60,"overallOfficials":69,"centralContacts":75,"locations":85,"responsibleParty":103,"collaborators":43,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":43,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":43,"enrollmentInfo":114,"targetDuration":43,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":132,"whyStopped":43,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Median Progression-Free Survival （mPFS）","The primary outcome will be median progression-free survival (mPFS), defined as the time from the date of first administration of study treatment to the first occurrence of objectively documented disease progression or death from any cause, whichever occurs first.\n\nmPFS will be used to evaluate the potential antitumor activity of FMT combined with Nalirifox plus serplulimab in treatment-naïve patients with locally advanced pancreatic ductal adenocarcinoma (PDAC).\n\nTumor response and disease progression will be assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Radiographic assessments will be performed at baseline and subsequently every 9 weeks （±1 week） during the treatment period.","From the first administration of study treatment dose of FMT until radiographic disease progression or death from any cause, whichever occurs first, up to approximately 1 year.",[14,17,21,25,28],{"measure":15,"description":16,"timeFrame":12},"Objective Response Rate （ORR）","ORR will be defined as the proportion of participants whose best overall response (BOR) during study treatment is either complete response (CR) or partial response (PR), as assessed according to RECIST v1.1.\n\nDetermined using RECIST 1.1 criteria to evaluate changes in tumour size on routine imaging and quantified using the Kaplan-Meier method.",{"measure":18,"description":19,"timeFrame":20},"Disease Control Rate （DCR）","DCR will be defined as the proportion of participants whose best overall response is CR, PR, or stable disease （SD） according to RECIST v1.1.","Starting from the first administration of study treatment dose of FMT to radiographic disease progression or death, up to approximately 1 year",{"measure":22,"description":23,"timeFrame":24},"Duration of Response （DoR）","DoR will be defined as the time from the date of the first documented CR or PR to the first assessed progressive disease (PD) or death from any cause, whichever occurs first.\n\nDuration of response will be evaluated among participants who achieve an objective response.","Starting from the first administration of study treatment dose of FMT to radiographic disease progression or death, up to approximately 1 year.",{"measure":26,"description":27,"timeFrame":24},"Overall Survival （OS）","OS will be defined as the time from the date of first administration of study treatment to death from any cause.\n\nFor participants who remain alive at the time of the last follow-up, OS will be censored at the date on which the participant was last confirmed to be alive.\n\nParticipants who are lost to follow-up, OS will be censored at the date of the last confirmed survival assessment.",{"measure":29,"description":30,"timeFrame":31},"Safety and Adverse Events","Safety and tolerability of the treatment strategy will be evaluated based on the incidence, severity, and characteristics of adverse events （AEs） occurring during the study. Safety analyses will include:\n\nAll treatment-emergent adverse events; Treatment-related adverse events; Serious adverse events （SAEs）; Treatment-related SAEs; Clinically significant laboratory abnormalities; and Changes in vital signs, physical examination findings, and electrocardiographic parameters.\n\nSafety assessments will be conducted from baseline through 30 days （±7 days） after the final administration of study treatment, with ongoing follow-up of clinically significant unsolved events according to the study protocol.\n\nAdverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI.CTCAE)","30 days",[33,37],{"measure":34,"description":35,"timeFrame":36},"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, before Nalirifox plus Serplulimab administration on Day 8, before the second FMT administration on Day 29, and before the third FMT administration on Day 50.",{"measure":38,"description":39,"timeFrame":36},"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.",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":43,"timePerspective":43,"maskingInfo":45},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":46,"maskingDescription":43,"whoMasked":43},"NONE","The main purpose of this phase II study is to assess the efficacy and safety of fecal microbiota transplantation （FMT） combined with NALIRIFOX plus Serplulimab as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC).\n\nThis study plans to enroll a total of 40 treatment-naïve patients diagnosed with locally advanced or metastatic PDAC and will be randomized in a 1:1 ratio to either the experimental group (group A, n=20） or the other group (group B, n=20）.\n\nThe primary objective is to evaluate the median progression-free survival （mPFS） of fecal microbiota transplantation （FMT） combined with NALIRIFOX plus Serplulimab in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC）.\n\nSecondary objectives are to determine the overall survival （OS）, objective response rate, disease control rate （DCR）, and duration of response （DoR） according to RECIST v1.1 criteria. Adverse drug events （ADEs) will be evaluated and graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events ( NCI-CTCAE) version 6.0.\n\nIn addition, this study aims to investigate multi-omics prognosis prediction biomarkers and their underlying mechanisms.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"FMT+Chemotherapy+Immunotherapy","EXPERIMENTAL","Polyethylene glycol bowel preparation will be performed on Day 0, followed by FMT administration on Day 1. Starting on Day 8, Nalirifox will be administered intravenously once every 14 days, and serplulimab will be administered intravenously once every 3 weeks. Two additional FMT administrations will be given concurrently with ICI administration.\n\nFor patients with stable or partial or complete response, the current treatment regimen will be continued in accordance with the study protocol.",[54],"Drug: FMT combined with chemotherapy plus immunotherapy",{"label":56,"type":6,"description":57,"interventionNames":58},"Chemotherapy+Immunotherapy","Starting on Day 8, Nalirifox will be administered intravenously once every 14 days for 4 cycles, and serplulimab will be administered intravenously once every 3 weeks for 3 cycles. Two additional FMT administrations will be given concurrently with ICI administration.",[59],"Drug: Chemotherapy+Immunotherapy",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":43},"DRUG","FMT combined with chemotherapy plus immunotherapy","Drug: Fecal Microbiota Transplantation\n\n* Fecal Microbiota Transplantation with 80- 100 g of healthy donor stool in 36-40 oral capsules Drug: NALIRIFOX Chemotherapy\n* Liposomal Irinotecan 50mg\u002Fm²\u002Fday IV for every two weeks\n* Oxaliplatin 60 mg\u002Fm²\u002Fday IV for every two weeks\n* Leucovorin 400 mg\u002Fm²\u002F day IV for every two weeks\n* 5-FU 2400 mg\u002F m² day IV for every two weeks Drug: Immunotherapy\n* Serplulimab 3mg\u002Fkg day IV for every three weeks",[50],{"type":62,"name":56,"description":67,"armGroupLabels":68,"otherNames":43},"Drug: NALIRIFOX Chemotherapy\n\n* Liposomal Irinotecan 50mg\u002Fm²\u002Fday IV for every two weeks\n* Oxaliplatin 60 mg\u002Fm²\u002Fday IV for every two weeks\n* Leucovorin 400 mg\u002Fm²\u002F day IV for every two weeks\n* 5-FU 2400 mg\u002F m² day IV for every two weeks Drug: Immunotherapy\n* Serplulimab 3mg\u002Fkg day IV for every three weeks",[56],[70,73],{"name":71,"affiliation":5,"role":72},"Hao Jihui, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":74,"affiliation":5,"role":72},"Zhang Ningning",[76,81],{"name":77,"role":78,"phone":79,"phoneExt":43,"email":80},"Zhang Ningning, MD, PhD","CONTACT","+8615822153931","mail4ningning@163.com",{"name":82,"role":78,"phone":83,"phoneExt":43,"email":84},"Yu Hao, PhD","+8613012284232","liuxiaotian116@163.com",[86],{"facility":5,"status":43,"city":87,"state":43,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Tianjin","300060","China","CN",{"type":92,"coordinates":93},"Point",[94,95],117.17667,39.14222,{"lat":95,"lon":94},[98,101,102],{"name":99,"role":78,"phone":100,"phoneExt":43,"email":84},"Liu Yue, PhD","+8615245104487",{"name":71,"role":72,"phone":43,"phoneExt":43,"email":43},{"name":77,"role":72,"phone":43,"phoneExt":43,"email":43},{"type":104,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100658805","phase-2-fecal-microbiota-transplantation-combined-with-nalirifox-plus-serplulimab-as-first-line-treatment-for-advanced-or-metastatic-pancreatic-ductal-adenocarcinoma-100658805",false,"NCT07854977","Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma.","Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Randomized, Open-Label, Single-Center, Parallel-Group, Prospective Phase II Clinical Study.","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that is locally advanced, unresectable with no prior systemic therapy for advanced disease.\n3. At least one measurable lesion per RECIST v1.1.\n4. Adequate hematologic, hepatic, renal, and coagulation function per protocol-defined laboratory criteria, and no clinically significant electrocardiographic abnormalities.\n5. Able to swallow capsules whole, and no systemic broad-spectrum antibiotic use within the protocol-defined washout period prior to enrollment.\n6. ECOG performance status of 0 or 1, and life expectancy of at least 3 months\n\nExclusion Criteria:\n\n1. Patients with metastatic disease, peritoneal metastasis, malignant ascites, or unsuitable for NALIRIFOX treatment.\n2. Patients with active autoimmune diseases or requiring systemic immunosuppressive therapy and patients with immunodeficiency, HIV infection, or history of organ\u002Fhematopoietic stem cell transplantation.\n3. Patients with uncontrolled infection, active hepatitis B\u002FC infection, or severe infectious diseases.\n4. Patients with gastrointestinal perforation, fistula, abscess, active bleeding, or contraindications to FMT.\n5. Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction.\n6. Patients with known hypersensitivity to study drugs or FMT-related components.","ALL","18 Years",{"count":115,"type":116},40,"ESTIMATED","INTERVENTIONAL",[119],"PHASE2","This single center, prospective, randomized, open-label, two-arm parallel-controlled Phase II clinical trial is designed to evaluate the efficacy and safety of fecal microbiota transplantation （FMT ）combined with Nalirifox plus Serplulimab as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)",[122,123],"Locally Advanced Pancreatic Ductal Adenocarcinoma","Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)",[125,126,127,128,129,130,131],"Fecal Microbial Transplantation","Nalirifox","Serplulimab","Liposomal Irinotecan","Oxaliplatin","Leucovorin","5-Fluorouracil (5-FU)","NOT_YET_RECRUITING","2026-09-27",{"date":135,"type":136},"2026-10-02","ACTUAL",{"date":138,"type":116},"2026-11",{"date":140,"type":116},"2030-05",{"name":5,"class":6},1]