[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657984":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":53,"overallOfficials":61,"centralContacts":67,"locations":76,"responsibleParty":95,"collaborators":33,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":33,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":33,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":125,"whyStopped":33,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Median Progression-Free Survival (mPFS)","The primary efficacy 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 SHR-1701 and nab-paclitaxel Plus Gemcitabine in the 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 dose of study treatment until the first documented radiographic disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 12 months.",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"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） from the beginning of the treatment until the first objective tumor progression throughout the entire study.","From the first dose of study treatment until documented disease progression or initiation of a new anticancer therapy, assessed up to 12 months.",{"measure":19,"description":20,"timeFrame":17},"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.",{"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","From the first documented complete or partial response until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months.",{"measure":26,"description":27,"timeFrame":28},"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.","From the first dose of study treatment until death from any cause, assessed up to 36 months.",{"measure":30,"description":31,"timeFrame":32},"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 ECG and laboratory abnormalities\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",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","This phase II study aims to assess the efficacy and safety of fecal microbiota transplantation （FMT) combined with SHR-1701plus Nab-paclitaxel and Gemcitabine as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC). This study plans to enroll a total of 60 treatment-naïve patients diagnosed with locally advanced or metastatic PDAC and participants will be randomized in a 1:1 ratio into experimental group (group A, n=30）or control group (group B, n=30） The primary objective is to evaluate the median progression free-survival （mPFS） of fecal microbiota transplantation （FMT） combined with SHR-1701 Plus AG chemotherapy in patients for locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC）.\n\nThe secondary objectives are to determine the overall survival （OS）, objective response rate （ORR）, disease control rate （DCR）, and duration of response （DoR） according to RECIST v1.1 criteria. Furthermore, to assess adverse drug events （ADEs） and other reported adverse events will be evaluated and graded in based on the NCI-CTCAE, version 6.0.\n\nAs exploratory objectives, this study aims to investigate multi-omics prognosis prediction biomarkers and their associated mechanisms.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"FMT+Chemotherapy+Immunotherapy","EXPERIMENTAL","Bowel preparation with Polyethylene Glycol is administered on Day 0, followed by Fecal Microbiota Transplantation （FMT） on Day 1. AG is administered intravenously at Day8，Day15 and Day 22 of each 28 days. SHR-1701 is also initiated on Day 8 and administered intravenously once every 3 weeks, with FMT given concurrently with each SHR-1701.If the patient's disease is assessed as not having progressed, the current treatment regimen will be continued. For patients with stable or partial or complete response, the current treatment regimen will be continued in accordance with the study protocol.",[47],"Drug: FMT+Chemotherapy+Immunotherapy",{"label":49,"type":6,"description":50,"interventionNames":51},"Chemotherapy+Immunotherapy","AG is administered intravenously at Day8，Day15 and Day 22 of each 28 days. SHR-1701 is also started on Day 8 and administered intravenously once every 3 weeks, for patients with stable or partial or complete response, the current treatment regimen will be continued in accordance with the study protocol.",[52],"Drug: Chemotherapy+Immunotherapy",[54,58],{"type":55,"name":43,"description":56,"armGroupLabels":57,"otherNames":33},"DRUG","Drug: Fecal Microbiota Transplantation\n\n* Fecal Microbiota Transplantation with 80- 100 g of healthy donor stool in 36-40 oral capsules Drug :AG Chemotherapy\n* Gemcitabine 1000 mg\u002Fm2\u002Fday IV on Days 1, 8, and 15 of each 28-day cycle.\n* nab-Paclitaxel 125 mg\u002Fm2\u002Fday IV on Days 1, 8, and 15 of each 28-day cycle. Drug: Immunotherapy\n* SHR-1701 30mg\u002Fkg IV every 3 week",[43],{"type":55,"name":49,"description":59,"armGroupLabels":60,"otherNames":33},"Drug :AG Chemotherapy\n\n* Gemcitabine 1000 mg\u002Fm2\u002Fday IV on Days 1, 8, and 15 of each 28-day cycle.\n* nab-Paclitaxel 125 mg\u002Fm2\u002Fday IV on Days 1, 8, and 15 of each 28-day cycle. Drug: Immunotherapy\n* SHR-1701 30mg\u002Fkg IV every 3 week",[49],[62,65],{"name":63,"affiliation":5,"role":64},"Hao Jihui, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":66,"affiliation":5,"role":64},"Zhang Ningning, MD, PhD",[68,72],{"name":66,"role":69,"phone":70,"phoneExt":33,"email":71},"CONTACT","+8615822153931","mail4ningning@163.com",{"name":73,"role":69,"phone":74,"phoneExt":33,"email":75},"Yu Hao, PhD","+8613012284232","tijmuyh@163.com",[77],{"facility":5,"status":33,"city":78,"state":33,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Tianjin","300060","China","CN",{"type":83,"coordinates":84},"Point",[85,86],117.17667,39.14222,{"lat":86,"lon":85},[89,90,93,94],{"name":66,"role":69,"phone":70,"phoneExt":33,"email":71},{"name":91,"role":69,"phone":33,"phoneExt":33,"email":92},"Liu Yue, PhD","liuxiaotian116@163.com",{"name":63,"role":64,"phone":33,"phoneExt":33,"email":33},{"name":66,"role":64,"phone":33,"phoneExt":33,"email":33},{"type":96,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100657984","phase-2-fmt-plus-shr-1701-with-nab-paclitaxelgemcitabine-as-first-line-treatment-for-locally-advanced-or-metastatic-pancreatic-ductal-adenocarcinomaa-phase-ii-study-100657984",false,"NCT07845565","FMT Plus SHR-1701 With Nab-Paclitaxel\u002FGemcitabine as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma","Fecal Microbiota Transplantation Combined With SHR-1701(an Anti-PD-L1\u002FTGF-βRII Fusion Protein) and Nab-Paclitaxel Plus Gemcitabine as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma：A Randomized, Open-Label, Single-Center, Two-Arm, Prospective Phase II Study","Inclusion criteria\n\n* 18-75 years\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that is locally advanced, unresectable with no prior systemic therapy for advanced disease.\n* At least one measurable lesion per RECIST v1.1.\n* Adequate hematologic, hepatic, renal, cardiac and coagulation function.\n* Have the ability to ingest capsule.\n* ECOG performance status of 0-1\n* Life expectancy of at least 3 months\n\nExclusion criteria\n\n* Patients with metastatic disease, peritoneal metastasis, malignant ascites, or unsuitable for NALIRIFOX treatment.\n* Patients with active autoimmune diseases or requiring systemic immunosuppressive therapy and patients with immunodeficiency, HIV infection, or history of organ\u002Fhematopoietic stem cell transplantation.\n* Patients with uncontrolled infection, active hepatitis B\u002FC infection, or severe infectious diseases.\n* Patients with gastrointestinal perforation, fistula, abscess, active bleeding, or contraindications to FMT.\n* Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction.\n* Patients with known hypersensitivity to study drugs or FMT-related components.","ALL","18 Years","75 Years",{"count":108,"type":109},60,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","This is a prospective, single-center, randomized, open-label, two-arm Phase II clinical trial design to evaluate the feasibility, safety and preliminary efficacy of combining fecal Fecal Microbiota Transplantation （FMT） Combined With SHR-1701plus Nab-paclitaxel and Gemcitabine as first-line treatment in patients for locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC）.",[115],"Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)",[117,118,119,120,121,122,123,124],"Fecal Microbial Transplantation （FMT）","Pancreatic Ductal Adenocarcinoma (PDAC)","Locally Advanced Pancreatic Ductal Adenocarcinoma","Metastatic Pancreatic Ductal Adenocarcinoma","SHR-1701","PD-L1\u002FTGF-βRII Fusion Protein","Nab-Paclitaxel","Gemcitabine","NOT_YET_RECRUITING","2026-09-28",{"date":128,"type":129},"2026-10-01","ACTUAL",{"date":131,"type":109},"2026-11",{"date":133,"type":109},"2030-05",{"name":5,"class":6},1]