[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610595":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":11,"centralContacts":44,"locations":53,"responsibleParty":80,"collaborators":11,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":11,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":11,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"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,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The First Affiliated Hospital, College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":63,"coordinates":64},"Point",[65,66],120.16142,30.29365,{"lat":66,"lon":65},[69,73,77,79],{"name":70,"role":47,"phone":71,"phoneExt":11,"email":72},"Yanbo Liang","+86-0571-87236688","liangtingbo@zju.edu.cn",{"name":74,"role":47,"phone":75,"phoneExt":11,"email":76},"Xueli Bai","+86-0571-87236857","shirleybai@zju.edu.cn",{"name":70,"role":78,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":74,"role":78,"phone":11,"phoneExt":11,"email":11},{"type":81,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610595","phase-3-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-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":93,"type":94},604,"ESTIMATED","INTERVENTIONAL",[97],"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.",[100],"Advanced Biliary Tract Cancer","2026-01-27",{"date":103,"type":104},"2026-01-28","ACTUAL",{"date":106,"type":104},"2026-01-21",{"date":108,"type":94},"2029-12",{"name":5,"class":6},1]