[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651079":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":27,"responsibleParty":43,"collaborators":27,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":27,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":27,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":27,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":27},{"fullName":5,"class":6},"Dongguan People's Hospital","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group：Lenvatinib + TMZ + radiotherapy","EXPERIMENTAL","Lenvatinib + TMZ + radiotherapy：During RT, TMZ 75 mg\u002Fm² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.",[13,14,15],"Drug: Lenvatinib","Drug: TMZ (Temozolomide)","Radiation: radiotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"control group：TMZ + radiotherapy","ACTIVE_COMPARATOR","TMZ + radiotherapy：During RT, TMZ 75 mg\u002Fm² po QD; 4 weeks after RT, 6 cycles of TMZ (150-200 mg\u002Fm² po D1-D5, Q4W) maintenance.",[14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Lenvatinib","Chemotherapy:Lenvatinib-TMZ Group: During RT, TMZ 75 mg\u002Fm² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"TMZ (Temozolomide)","Chemotherapy: TMZ Group: During RT, TMZ 75 mg\u002Fm² po QD; 4 weeks after RT, 6 cycles",[17,9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"RADIATION","radiotherapy","Starts 2-6 weeks post-op; total dose 60 Gy (2.0 Gy\u002Ffraction, 30 fractions) over 6-7 weeks.",[17,9],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Zhigang Liu, PostDoc Fellow","CONTACT","0769-28637916","zhigangliu1983@hotmail.com",{"type":44,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100651079","stupp-regimen-with-or-without-lenvatinib-for-newly-diagnosed-glioblastoma-with-mgmt-promoter-methylation-100651079",false,"NCT07754734","STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation","STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation: A Multicenter, Randomized Phase II Clinical Trial","Inclusion Criteria:\n\n* Newly diagnosed GBM confirmed by post-op pathology\u002Fbiopsy, MGMT promoter methylation positive, no prior RT or chemo.\n* Surgery\u002Fbiopsy ≤ 21 days before enrollment.\n* Age 18-75 years any gender.\n* KPS ≥ 70.\n* Organ function (no blood components or growth factors within 14 days):\n\n  1. ANC ≥ 1.5 × 10⁹\u002FL; PLT ≥ 100 × 10⁹\u002FL; Hb ≥ 90 g\u002FL.\n  2. Total bilirubin ≤ 1.5 × ULN.\n  3. ALT, AST ≤ 3 × ULN.\n  4. Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL\u002Fmin.\n* Life expectancy ≥ 12 weeks.\n* Stable or tapering corticosteroid dose for 14 days.\n* Voluntary participation, signed informed consent, and good compliance.\n\nExclusion Criteria:\n\n* Allergy to Lenvatinib, TMZ, or components.\n* Other malignancies within 5 years or concurrent, or prior anti-tumor therapy.\n* Concurrent participation in another clinical trial (except observational).\n* Comorbidities interfering with treatment:\n\n  1. Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).\n  2. Conditions interfering with oral drugs (dysphagia, chronic diarrhea, bowel obstruction).\n* Evidence of increased intracranial pressure (midline shift \\> 5 mm, papilledema, vomiting, decreased consciousness).\n* History of drug\u002Falcohol abuse.\n* Pregnancy or lactation.\n* Other conditions judged by the investigator (e.g., unstable heart\u002Fkidney disease, uncontrolled diabetes, mood disorders).","ALL","18 Years","75 Years",{"count":56,"type":57},138,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive.",[63,64,65],"Glioma","Glioblastoma (GBM)","MGMT-Methylated Glioblastoma",[67,24,68,69],"Stupp regimen","phase II clinical trial","glioblastoma and MGMT promoter methylation","NOT_YET_RECRUITING","2026-08-06",{"date":73,"type":74},"2026-08-10","ACTUAL",{"date":73,"type":57},{"date":77,"type":57},"2029-07-31",{"name":5,"class":6}]