[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647029":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":28,"responsibleParty":44,"collaborators":18,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":18,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":70,"whyStopped":18,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy","EXPERIMENTAL","Participants will receive stereotactic body radiotherapy at 5-10 Gy in 5 fractions, followed one week later by sequential systemic therapy with ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg\u002Fkg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel 125 mg\u002Fm² and gemcitabine 1000 mg\u002Fm² will be administered on Days 1 and 8 of each 3-week cycle. AG chemotherapy will be given for 6 to 8 cycles, and sintilimab may continue as maintenance therapy until disease progression or other protocol-specified discontinuation criteria.",[13],"Drug: SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Jinbo Yue, Doctor","PRINCIPAL_INVESTIGATOR",[24],{"name":21,"role":25,"phone":26,"phoneExt":18,"email":27},"CONTACT","0531-67626442","jbyue@sdfmu.edu.cn",[29],{"facility":5,"status":18,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Jinan","Shandong","0531","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.99722,36.66833,{"lat":39,"lon":38},[42],{"name":43,"role":25,"phone":26,"phoneExt":18,"email":27},"Jinbo Yue",{"type":22,"investigatorFullName":43,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Director of Radiation Oncology Department","100647029","phase-2-sbrt-followed-by-ipilimumab-n01-sintilimab-nab-paclitaxel-and-gemcitabine-for-locally-advanced-pancreatic-cancer-100647029",false,"NCT07683221","SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer","Stereotactic Body Radiotherapy Followed by Ipilimumab N01 Plus Sintilimab in Combination With Nab-Paclitaxel and Gemcitabine for the Treatment of Locally Advanced Pancreatic Cancer: A Phase II, Prospective, Single-Arm Exploratory Clinical Trial","Inclusion Criteria:\n\n* Participants voluntarily agree to participate in the study, sign the informed consent form, and are willing and able to comply with study procedures and follow-up.\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.\n* Locally advanced unresectable pancreatic cancer without distant metastasis, confirmed by multidisciplinary team evaluation.\n* Age 18 to 75 years, inclusive.\n* Eastern Cooperative Oncology Group performance status of 0 to 1.\n* Life expectancy of at least 3 months.\n* No prior systemic therapy for advanced pancreatic cancer.\n* At least one measurable lesion according to RECIST 1.1.\n\nExclusion Criteria:\n\n* Participation in another anti-cancer drug clinical trial within 4 weeks before enrollment.\n* Prior targeted therapy or prior treatment with immune checkpoint inhibitors.\n* Presence of distant organ metastasis, including liver, peritoneal, brain, or meningeal metastasis.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.","ALL","18 Years","75 Years",{"count":57,"type":58},47,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","This is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Eligible patients will receive SBRT followed by sequential systemic therapy. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety.",[64],"Pancreatic Cancer",[66,67,68,69],"SBRT","Ipilimumab","Sintilimab","Locally Advanced Pancreatic Cancer","NOT_YET_RECRUITING","2026-06-28",{"date":73,"type":74},"2026-07-06","ACTUAL",{"date":76,"type":58},"2026-07-15",{"date":78,"type":58},"2029-07-15",{"name":5,"class":6},1]