[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638733":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":102,"collaborators":20,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":20,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":134,"whyStopped":20,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Anlotinib + Epirubicin","EXPERIMENTAL","Participants receive neoadjuvant therapy for 2 cycles (each cycle is 21 days). Anlotinib 10 mg orally once daily on days 1-14 (2 weeks on, 1 week off). Epirubicin 70 mg\u002Fm² intravenous infusion on day 1 of each cycle. After completion of neoadjuvant therapy, participants undergo radical surgery followed by postoperative radiotherapy as per protocol.",[13],"Drug: Anlotinib + Epirubicin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Anlotinib + Epirubicin","Anlotinib 10 mg orally once daily on days 1-14 of each 21-day cycle (2 weeks on, 1 week off) for 2 cycles.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Quan Liu, MD","CONTACT","+86 15001959681","liuqent@163.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Wanpeng Li, MD","+86 13262856870","18879117831@163.com",[32,50,65,80,95],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Xuanwu Hospital, Capital Medical University","Beijing","Beijing Municipality","100053","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":48,"phoneExt":49,"email":48},"Zhenlin Wang, MD","wzl1812@163.com","010-83198899",{"facility":51,"status":20,"city":52,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"The Third Affiliated Hospital of Sun Yat-sen University","Guangzhou","Guangdong","510630",{"type":40,"coordinates":56},[57,58],113.25,23.11667,{"lat":58,"lon":57},[61],{"name":62,"role":24,"phone":63,"phoneExt":20,"email":64},"Zhaohui Shi, MD","020-85253333","zhaohuishi@139.com",{"facility":66,"status":20,"city":67,"state":68,"zip":69,"country":37,"countryCode":38,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"The Affiliated Hospital of Qingdao University","Qingdao","Shandong","266000",{"type":40,"coordinates":71},[72,73],120.38042,36.06488,{"lat":73,"lon":72},[76],{"name":77,"role":24,"phone":78,"phoneExt":20,"email":79},"Yan Jiang, MD","0532-82911847","jiangyanoto@163.com",{"facility":81,"status":20,"city":82,"state":83,"zip":84,"country":37,"countryCode":38,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Zhongshan Hospital, Fudan University","Shanghai","Shanghai Municipality","200030",{"type":40,"coordinates":86},[87,88],121.45806,31.22222,{"lat":88,"lon":87},[91],{"name":92,"role":24,"phone":93,"phoneExt":20,"email":94},"Xinsheng Huang, MD","021-64041990","huang.xinsheng@zs-hospital.sh.cn",{"facility":5,"status":20,"city":82,"state":83,"zip":96,"country":37,"countryCode":38,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"200031",{"type":40,"coordinates":98},[87,88],{"lat":88,"lon":87},[101],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Quan Liu","Principal Investigator","100638733","phase-2-neoadjuvant-anlotinib-and-epirubicin-for-t4-sinonasal-adenoid-cystic-carcinoma-100638733",false,"NCT07616141","Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma","Neoadjuvant Anlotinib Combined With Epirubicin for T4 Stage Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial","NAET4-SNACC","Inclusion Criteria:\n\n* Age 18 to 75 years, any sex.\n* Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype).\n* Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable.\n* Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate bone marrow, liver, kidney, and cardiac function: absolute neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL; ALT\u002FAST ≤2.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN; creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin; left ventricular ejection fraction (LVEF) ≥50%.\n* Willing to participate and able to provide written informed consent (including for clinical treatment and translational research).\n\nExclusion Criteria:\n\n* Prior radiotherapy to the head and neck region.\n* Prior anthracycline therapy with cumulative dose ≥300 mg\u002Fm².\n* Known hypersensitivity to any component of anlotinib or epirubicin.\n* Uncontrolled hypertension, severe cardiovascular disease, or active infection.\n* Pregnant or breastfeeding women.\n* Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study compliance or conduct.","ALL","18 Years","75 Years",{"count":118,"type":119},76,"ESTIMATED","INTERVENTIONAL",[122],"PHASE2","T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. The goal of this study is to test whether a new combination of drugs given before surgery - anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug) - can improve outcomes for patients with T4 SNACC.\n\nThis is a prospective, multicenter, single-arm, phase II clinical trial. Eligible participants will receive 2 cycles of neoadjuvant treatment (anlotinib orally for 2 weeks on\u002F1 week off, plus epirubicin intravenously on day 1 of each 3-week cycle). After completing neoadjuvant therapy, participants will undergo surgery to remove the tumor, followed by postoperative radiotherapy. The main question the study tries to answer is whether this approach increases the 3-year progression-free survival (PFS) rate compared to the historical rate of about 70% with standard treatment (surgery plus radiotherapy alone). Secondary questions include how many tumors shrink after neoadjuvant treatment, how many operations achieve complete removal with negative margins, major pathological response rates, overall survival, safety, quality of life, and the chance of avoiding disfiguring surgeries (such as removal of the eye or part of the skull). The study will enroll about 76 participants from 5 top medical centers in China. If positive, this study may establish a new standard of care for T4 SNACC.",[125],"Adenoid Cystic Carcinoma",[125,127,128,129,130,131,132,133],"Sinonasal","T4 Stage","Neoadjuvant Therapy","Anlotinib","Epirubicin","Prospective Study","Phase II Clinical Trial","NOT_YET_RECRUITING","2026-05-23",{"date":137,"type":138},"2026-06-01","ACTUAL",{"date":137,"type":119},{"date":141,"type":119},"2031-06-01",{"name":5,"class":6},5]