[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518985":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":20,"responsibleParty":35,"collaborators":20,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":20,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":20,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":20},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine\u002Fcisplatin followed by the operation",[13],"Drug: Total Neoadjuvant Treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Total Neoadjuvant Treatment","Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg\u002Fm2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg\u002Fm2) every three weeks on days 1 and 8 intravenously",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Xiangcheng Li","STUDY_CHAIR",{"name":26,"affiliation":5,"role":27},"Xiaofeng Chen","PRINCIPAL_INVESTIGATOR",[29,33],{"name":23,"role":30,"phone":31,"phoneExt":20,"email":32},"CONTACT","18951999088","drlixc@163.com",{"name":26,"role":30,"phone":34,"phoneExt":20,"email":20},"13585172066",{"type":36,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100518985","phase-2-chemotherapy-combined-with-adebrelimab-and-mecapegfilgrastim-in-neoadjuvant-treatment-of-potentially-resectable-btc-100518985",false,"NCT06037655","Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC","Gemcitabine\u002FCisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study","Modified","Inclusion Criteria:\n\n* Male or female\n* Age ≥ 18 years，≤ 75 years\n* Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically\n* Ability to provide written informed consent prior to participation in any study-related procedure\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma\n* Known history of a serious allergy to any monoclonal antibody\n* Any active malignancy prior to the start of treatment\n* Active or history of autoimmune disease\n* Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation\n* Pregnant or lactating women","ALL","18 Years","75 Years",{"count":49,"type":50},30,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","The purpose of this study is to assess the safety and efficacy of Gemcitabine\u002Fcisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.",[56],"Biliary Tract Neoplasms","NOT_YET_RECRUITING","2023-09-07",{"date":60,"type":61},"2023-09-14","ACTUAL",{"date":63,"type":50},"2023-09-25",{"date":65,"type":50},"2026-12-31",{"name":5,"class":6}]