[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545224":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":63,"collaborators":21,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":21,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":21,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":21,"overallStatus":38,"whyStopped":21,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Obese EEC group","EXPERIMENTAL","This group including 29 EEC cases. Interventional Study Model was Simon two-stage optimal design. Eleven patients were needed for the first stage, and if eight or more patients achieved CR at 28 weeks, the trial can enter into the second stage.\n\nThen every 12 to 16 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.",[13,14],"Drug: GnRH antagonist","Drug: Letrozole 2.5mg",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","GnRH antagonist","Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks, and the maximum treatment courses will be 6. If the patient get CR within 6 courses, another 2 courses will be used as consolidation therapy.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Letrozole 2.5mg","2.5mg po qd.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Xiaojun Chen, PhD","CONTACT","8602133189900","cxjlhjj@163.com",{"name":33,"role":29,"phone":30,"phoneExt":21,"email":34},"Pengfei Wu","leofinger@163.com",[36,54],{"facility":37,"status":38,"city":39,"state":40,"zip":21,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Tenth People's Hospital of Tongji University","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":21,"email":53},"Weina Wang","8602166300588","wangweinals@163.com",{"facility":55,"status":38,"city":39,"state":21,"zip":21,"country":41,"countryCode":42,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Obstetrics and Gynecology Hospital, Fudan University",{"type":44,"coordinates":57},[46,47],{"lat":47,"lon":46},[60],{"name":61,"role":29,"phone":62,"phoneExt":21,"email":31},"Xiaojun Chen","862133189900",{"type":64,"investigatorFullName":61,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Professor","100545224","phase-2-gnrha--letrozole-in-obese-progestin-insensitive-endometrial-cancer-patients-100545224",false,"NCT06379113","GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients","Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Early-stage Endometrial Cancer Patients With Conservative Treatment","Inclusion Criteria:\n\n* Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion\n* BMI≥30kg\u002Fm2\n* No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound\n* Using progestin, any of the following therapy, as first-line treatment:\n\n  1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not\n  2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not\n  3. LNG-IUS inserted\n* Progestin-insensitive:\n\n  1. remained with stable disease after 7 months of progestin use\n  2. did not achieve CR after 10 months of progestin use\n* Have a desire for remaining reproductive function or uterus\n* Good compliance with adjunctive treatment and follow-up\n\nExclusion Criteria:\n\n* Combined with severe medical disease or severely impaired liver and kidney function\n* Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis\n* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system\n* Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with GnRHa or Letrozole\n* Strong request for uterine removal or other conservative treatment\n* Known or suspected pregnancy\n* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease\n* Smoker(\\>15 cigarettes a day)","FEMALE","18 Years","45 Years",{"count":77,"type":78},29,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE2","PHASE3","To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.",[85,86,87,88],"Endometrial Neoplasms","Atypical Endometrial Hyperplasia","Progesterone Resistance","Obesity","2025-08-06",{"date":91,"type":92},"2025-08-11","ACTUAL",{"date":94,"type":92},"2022-07-13",{"date":96,"type":78},"2027-03-30",{"name":61,"class":6},2]