[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589960":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":38,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":83,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy","EXPERIMENTAL",null,[13,14],"Drug: Nano-crystalline Megestrol Acetate Oral Suspension","Drug: standard treatment",{"label":16,"type":17,"description":11,"interventionNames":18},"Standard Therapy","ACTIVE_COMPARATOR",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Nano-crystalline Megestrol Acetate Oral Suspension","Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg\u002FmL, the study group takes 5 mL orally per day (625 mg\u002Fday), and continues medication.",[9],{"type":21,"name":26,"description":26,"armGroupLabels":27,"otherNames":11},"standard treatment",[9,16],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Lu Li","CONTACT","18980601778","windflower1991@vip.163.com",{"name":35,"role":31,"phone":36,"phoneExt":11,"email":37},"Dan Pu","13348826654","danpu_87@163.com",[39],{"facility":40,"status":11,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"West China School of Medicine\u002FWest China Hospital of Sichuan University","Chengdu","Sichuan","610000","China","CN",{"type":47,"coordinates":48},"Point",[49,50],104.06667,30.66667,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":11,"email":56},"Qiongwen Zhang","18683716951","qiongwen.zhang@scu.edu.cn",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[60],{"name":61,"class":62},"West China Hospital","OTHER","100589960","phase-3-nano-crystalline-megestrol-acetate-combined-with-standard-treatment-versus-standard-treatment-for-first-line-extensive-stage-small-cell-lung-cancer-in-the-cachexia-phase-100589960",false,"NCT06961201","Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase","A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer (ES-SCLC) in the Cachexia Phase","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Life expectancy of ≥6 months.\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (according to the Veterans Administration Lung Study Group (VALG) staging system).\n* Participants must not have previously received systemic chemotherapy for ES-SCLC. For participants who have previously received adjuvant\u002Fneoadjuvant chemotherapy for non-metastatic disease with curative intent or concurrent\u002Fsequential chemoradiotherapy for locally advanced disease, they are eligible for this study if disease progression occurs \\>6 months after the completion of the last treatment.\n* Participants who have previously received PD-1\u002FL1 inhibitors in the neoadjuvant setting are allowed to participate in this study after investigator assessment and agreement. Participants who have previously received PD-1\u002FL1 inhibitors in the adjuvant setting or as consolidation therapy after curative chemoradiotherapy are not eligible for this study.\n* At least one measurable tumor lesion according to RECIST v1.1.\n* Meet the criteria for pre-cachexia or cachexia diagnosis (based on the Fearon diagnostic criteria).\n\nExclusion Criteria:\n\n* Presence of conditions that may affect gastrointestinal absorption, such as dysphagia, malabsorption, history of gastrectomy, or uncontrollable vomiting; ongoing enteral feeding or parenteral nutrition; or anorexia due to neurological causes, psychiatric conditions, or pain that makes eating difficult.\n* Currently taking or planning to take other medications that increase appetite or weight, such as corticosteroids (excluding short-term use of dexamethasone during chemotherapy), androgens, progestogens, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n* Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes mellitus.\n* Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional trial or the follow-up period of an interventional study.\n* Presence of unresolved toxicities from prior anti-tumor treatments. Unresolved is defined as not having returned to Grade 0 or 1 according to NCI CTCAE Version 5.0 (except for alopecia) or not having returned to the levels specified in the enrollment\u002Fexclusion criteria.","ALL","18 Years","85 Years",{"count":74,"type":75},94,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","This study is a prospective, randomized, parallel-controlled clinical trial, aiming to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) in both the pre-cachexia and cachexia phases. Participants enrolled in the study are those with ES-SCLC in the pre-cachexia or cachexia phase who have not received systemic treatment and are not eligible for curative therapy.",[81,82],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy","NOT_YET_RECRUITING","2025-04-29",{"date":86,"type":87},"2025-05-07","ACTUAL",{"date":89,"type":75},"2025-05-01",{"date":91,"type":75},"2027-06-30",{"name":5,"class":6},1]