[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592066":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":44,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"BTC cohort",null,[12],"Drug: GemCis plus PD-1\u002FPD-L1 inhibitor",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","GemCis plus PD-1\u002FPD-L1 inhibitor","Gemcitabine: 1000 mg\u002Fm², intravenous infusion, on Day 1 and Day 8 Cisplatin: 25 mg\u002Fm², intravenous infusion, on Day 1 and Day 8 PD-1\u002FPD-L1 inhibitor: An approved agent (e.g., Pembrolizumab, Nivolumab, Atezolizumab, etc.) will be selected based on clinical practice and administered at standard doses and schedules.\n\nEach treatment cycle lasts 21 days, continuing until disease progression, unacceptable toxicity, or patient\u002Fphysician decision to discontinue.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Peng Wang, MD","CONTACT","86-21-64041990","peng_wang@fudan.edu.cn",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":43,"phoneExt":10,"email":24},"Peng Wang","+86021-64041990",{"type":45,"investigatorFullName":42,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Professor","100592066","gemcis-plus-pd-1pd-l1-inhibitor-in-advanced-biliary-tract-cancer-efficacy-and-immune-microenvironment-btc-im-1-100592066",false,"NCT06988592","GemCis Plus PD-1\u002FPD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）","A Prospective, Non-interventional Study of Gemcitabine\u002FCisplatin Combined With PD-1\u002FPD-L1 Inhibitor as First-line Treatment in Treatment-naïve Advanced Biliary Tract Cancer Patients: Efficacy and Immune Microenvironment Dynamics","BTC-IM-1","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed unresectable\u002Fmetastatic cholangiocarcinoma (intrahepatic, extrahepatic, or gallbladder).\n* No prior systemic anticancer therapy (chemotherapy, targeted therapy, or immunotherapy).\n* Planned to receive GemCis+PD-1\u002FPD-L1 inhibitor as standard first-line treatment.\n* ≥1 measurable lesion per RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate organ function:\n\n  * ANC ≥1.5 × 10⁹\u002FL, platelets ≥100 × 10⁹\u002FL, hemoglobin ≥9 g\u002FdL.\n  * Total bilirubin ≤1.5 × ULN, AST\u002FALT ≤3 × ULN (≤5 × ULN if liver metastases).\n  * Creatinine ≤1.5 × ULN or CrCl ≥60 mL\u002Fmin.\n* Willing to provide archival\u002Ffresh tumor tissue and peripheral blood samples.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy.\n* Active autoimmune disease requiring immunosuppression.\n* Active infection requiring IV antibiotics.\n* HIV-positive or active HBV\u002FHCV infection (HBsAg+ with HBV DNA ≥2000 IU\u002FmL; HCV RNA+).\n* Symptomatic CNS metastases.\n* Pregnancy\u002Flactation.\n* Any condition compromising protocol compliance or data interpretation per investigator.","ALL","18 Years",{"count":58,"type":59},100,"ESTIMATED","OBSERVATIONAL","To evaluate the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine\u002Fcisplatin (GemCis) combined with PD-1\u002FPD-L1 inhibitors.",[63],"Advanced Biliary Tract Cancer","2025-05-22",{"date":66,"type":67},"2025-05-29","ACTUAL",{"date":69,"type":67},"2025-05-23",{"date":71,"type":59},"2027-12-30",{"name":5,"class":6},1]