[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610595":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":11,"centralContacts":44,"locations":53,"responsibleParty":79,"collaborators":11,"id":81,"slug":11,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":11,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":11,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group","EXPERIMENTAL",null,[13,14,15,16],"Drug: SHR-8068 Injection","Drug: Adebrelimab Injection","Drug: Gemcitabine Hydrochloride for Injection","Drug: Cisplatin Injection",{"label":18,"type":19,"description":11,"interventionNames":20},"Durvalumab + Cisplatin and Gemcitabine Group","ACTIVE_COMPARATOR",[15,16,21],"Drug: Durvalumab Injection",[23,28,32,36,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","SHR-8068 Injection","SHR-8068 injection.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Adebrelimab Injection","Adebrelimab injection.",[9],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Gemcitabine Hydrochloride for Injection","Gemcitabine Hydrochloride for injection.",[18,9],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Cisplatin Injection","Cisplatin injection.",[18,9],{"type":24,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Durvalumab Injection","Durvalumab injection.",[18],[45,50],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"Xin Shi","CONTACT","+86-0518-82342973","xin.shi.xs3@hengrui.com",{"name":51,"role":47,"phone":48,"phoneExt":11,"email":52},"Xin Xu","xin.xu@hengrui.com",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"The First Affiliated Hospital, College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310003","China",{"type":62,"coordinates":63},"Point",[64,65],120.16142,30.29365,{"lat":65,"lon":64},[68,72,76,78],{"name":69,"role":47,"phone":70,"phoneExt":11,"email":71},"Yanbo Liang","+86-0571-87236688","liangtingbo@zju.edu.cn",{"name":73,"role":47,"phone":74,"phoneExt":11,"email":75},"Xueli Bai","+86-0571-87236857","shirleybai@zju.edu.cn",{"name":69,"role":77,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":73,"role":77,"phone":11,"phoneExt":11,"email":11},{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610595",false,"NCT07229625","A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)","A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)","Inclusion Criteria:\n\n1. Locally advanced or recurrent\u002Fmetastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;\n2. No previous systemic anti-tumor treatment has been received;\n3. At least one measurable lesion that complies with the RECIST v1.1 standard;\n4. ECOG PS score: 0-1 point;\n5. The expected survival period is ≥ 3 months;\n6. Good organ function level;\n7. Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;\n8. Patients voluntarily joined this study and signed informed consent.\n\nExclusion Criteria:\n\n1. Other pathological types of cholangiocarcinoma other than adenocarcinoma;\n2. Malignant tumor of the ampulla;\n3. Have had or concurrently suffered from other malignant tumors;\n4. Those with concurrent biliary obstruction and at risk of biliary tract infection;\n5. Those with any active or known autoimmune diseases.","ALL","18 Years","75 Years",{"count":91,"type":92},604,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.",[98],"Advanced Biliary Tract Cancer","2026-01-27",{"date":101,"type":102},"2026-01-28","ACTUAL",{"date":104,"type":102},"2026-01-21",{"date":106,"type":92},"2029-12",{"name":5,"class":6},1]