[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595260":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":44,"locations":49,"responsibleParty":66,"collaborators":23,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":23,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":23,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":51,"whyStopped":23,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tislelizumab + SBRT + GP Chemotherapy","EXPERIMENTAL","Participants will receive neoadjuvant stereotactic body radiotherapy (SBRT) followed by three cycles of combination therapy with tislelizumab and GP chemotherapy.\n\nSBRT: 5 Gy × 5-8 fractions or 4 Gy × 15 fractions to the primary tumor. Tislelizumab: 200 mg intravenously every 3 weeks (Day 1 of each cycle). Gemcitabine: 1000 mg\u002Fm² IV on Days 1 and 8 of each 21-day cycle. Cisplatin: 25 mg\u002Fm² IV on Days 1 and 8 OR Oxaliplatin: 100 mg\u002Fm² IV on Day 1 (based on clinical condition). After three cycles, patients will undergo re-evaluation. Those deemed resectable will undergo surgery and receive postoperative therapy based on multidisciplinary assessment. Patients remaining unresectable will receive an additional three cycles of the same systemic therapy.",[13,14,15,16],"Radiation: Stereotactic Body Radiotherapy (SBRT)","Drug: Tislelizumab","Drug: Gemcitabine","Drug: Cisplatin or Oxaliplatin",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"RADIATION","Stereotactic Body Radiotherapy (SBRT)","SBRT to the primary tumor and metastatic lymph node at a dose of either 5 Gy × 5-8 fractions or 4 Gy × 15 fractions, delivered prior to systemic therapy.",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"DRUG","Tislelizumab","Tislelizumab 200 mg administered intravenously every 3 weeks (on Day 1 of each 21-day cycle), for three to six cycles depending on surgical eligibility.",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Gemcitabine","Gemcitabine 1000 mg\u002Fm² administered intravenously on Days 1 and 8 of each 21-day cycle, for three to six cycles.",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Cisplatin or Oxaliplatin","Cisplatin 25 mg\u002Fm² on Days 1 and 8 or oxaliplatin 100 mg\u002Fm² on Day 1 of each 21-day cycle, selected based on patient condition, for three to six cycles.",[9],[38,41],{"name":39,"affiliation":5,"role":40},"Jinbo Yue","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":43},"Bo Zhang","STUDY_CHAIR",[45],{"name":39,"role":46,"phone":47,"phoneExt":23,"email":48},"CONTACT","053167626442","jbyue@sdfmu.edu.cn",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Jinan","Shandong","250117","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.99722,36.66833,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":47,"phoneExt":23,"email":48},"Jinbo MD, doctor",{"type":67,"investigatorFullName":39,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Chief Physician, Radiation Oncology","100595260","phase-2-phase-ii-study-of-neoadjuvant-tislelizumab-plus-radiotherapy-and-gp-chemotherapy-for-borderlineunresectable-hilar-cholangiocarcinoma-100595260",false,"NCT07030140","Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline\u002FUnresectable Hilar Cholangiocarcinoma","A Phase II, Single-arm, Prospective Clinical Study of Neoadjuvant Therapy With Tislelizumab Combined With Radiotherapy and Gemcitabine-Platinum Chemotherapy for Borderline Resectable or Unresectable Hilar Cholangiocarcinoma","Inclusion Criteria:\n\n* Age 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma\n* Borderline resectable or unresectable disease based on imaging and MDT evaluation\n* ECOG performance status 0-1\n* Adequate hematologic, hepatic, and renal function\n* No prior anti-tumor therapy for current diagnosis\n* Expected survival ≥ 3 months\n* Signed informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis\n* Prior treatment with immune checkpoint inhibitors\n* Uncontrolled infection or serious medical comorbidities\n* Active autoimmune disease requiring systemic therapy\n* History of organ transplantation or immunodeficiency\n* Pregnancy or lactation","ALL","18 Years","75 Years",{"count":80,"type":81},38,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This is a phase II, single-arm, prospective clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy combining stereotactic body radiotherapy (SBRT), GP chemotherapy (gemcitabine and cisplatin\u002Foxaliplatin), and tislelizumab in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Eligible patients will receive SBRT followed by three cycles of tislelizumab plus GP chemotherapy. Patients with resectable disease after evaluation may undergo surgery and receive postoperative treatment as recommended by the multidisciplinary team. Those who remain unresectable will receive three additional cycles of systemic therapy. The primary endpoint is overall survival (OS); secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, progression-free survival (PFS), local control rate, and treatment-related safety.",[87,88,89],"Cholangiocarcinoma","Hilar Cholangiocarcinoma","Bile Duct Cancer",[91,92,93,26,30,94,95,96,97,98,99,100],"Borderline Resectable","Unresectable","SBRT","Cisplatin","Oxaliplatin","Neoadjuvant Therapy","Immunotherapy","Radiation Therapy","PD-1 Inhibitor","Biliary Tract Cancer","2026-04-27",{"date":103,"type":104},"2026-05-01","ACTUAL",{"date":106,"type":104},"2025-07-01",{"date":108,"type":81},"2028-01-01",{"name":39,"class":6},1]