[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639075":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":46,"studyPopulation":11,"armGroups":47,"interventions":60,"overallOfficials":11,"centralContacts":68,"locations":11,"responsibleParty":74,"collaborators":11,"id":76,"slug":11,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":11,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":11,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":11},{"fullName":5,"class":6},"Shanghai Runshi Pharmaceutical Technology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC",null,"Up to approximately 4 years",[14,16,18,20,22,24,26,28,31,33,35,37],{"measure":15,"description":11,"timeFrame":12},"PFS as Assessed by RANO Criteria and Evaluated by investigators",{"measure":17,"description":11,"timeFrame":12},"Overall Survival (OS)",{"measure":19,"description":11,"timeFrame":12},"Overall Survival Rate at 12 Months (OS-12)",{"measure":21,"description":11,"timeFrame":12},"Progression Free Survival Rate at 6 Months (PFS-6) as Assessed by RANO Criteria",{"measure":23,"description":11,"timeFrame":12},"Objective Response Rate (ORR) as Assessed by RANO Criteria",{"measure":25,"description":11,"timeFrame":12},"Disease Control Rate (DCR) as Assessed by RANO Criteria",{"measure":27,"description":11,"timeFrame":12},"Frequency and severity of TEAEs and SAEs",{"measure":29,"description":11,"timeFrame":30},"Cmax of SYHA1813","Cycles 1, 2, 3",{"measure":32,"description":11,"timeFrame":30},"Tmax of SYHA1813",{"measure":34,"description":11,"timeFrame":30},"AUClast of SYHA1813",{"measure":36,"description":11,"timeFrame":30},"AUCinf of SYHA1813",{"measure":38,"description":11,"timeFrame":30},"t1\u002F2 of SYHA1813",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":11,"timePerspective":11,"maskingInfo":44},"RANDOMIZED","PARALLEL","This is a randomized, controlled, open-label, multicenter, Phase III clinical trial. Participants with recurrent or progressive high-grade meningioma (WHO Grade II and III) who have received surgical resection and radiotherapy and are not eligible for local therapy judged by investigator will be randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment.","TREATMENT",{"masking":45,"maskingDescription":11,"whoMasked":11},"NONE","Approximately136 participants with recurrent or progressive high-grade meningioma who have received surgical resection and radiotherapy will be enrolled and randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment. The primary endpoint is progression-free survival (PFS) assessed by blinded Independent Review Committee (BIRC) using the Response Assessment in Neuro-Oncology Working Group (RANO criteria) for meningioma.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Experimental group","EXPERIMENTAL","SYHA1813",[53],"Drug: SYHA1813",{"label":55,"type":56,"description":57,"interventionNames":58},"Control group","ACTIVE_COMPARATOR","Investigator's Choice Treatment",[59],"Drug: Investigator's Choice Treatment",[61,65],{"type":62,"name":51,"description":63,"armGroupLabels":64,"otherNames":11},"DRUG","SYHA1813 20mg QD",[49],{"type":62,"name":57,"description":66,"armGroupLabels":67,"otherNames":11},"Investigator's Choice Treatment：bevacizumab, temozolomide or hydroxyurea",[55],[69],{"name":70,"role":71,"phone":72,"phoneExt":11,"email":73},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":75,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639075",false,"NCT07613450","A Phase III Study of SYHA1813 for Recurrent or Progressive High-Grade Meningiomas","SYHA1813 vs Investigators' Choice Treatment in Patients With Recurrent or Progressive High-Grade Meningiomas: A Randomized, Controlled, Multicenter, Phase III Study","Inclusion Criteria:\n\n* 1\\. Aged \\>= 18 years.\n* 2\\. Histologically confirmed WHO grade II\u002FIII meningioma (WHO CNS 5th) that is progressive or recurrent.\n* 3\\. Individuals must have received surgery and radiation therapy.\n* 4\\. There is at least one measurable intracranial tumor lesion in the baseline period (RANO-meningioma).\n* 5\\. KPS≥60.\n* 6\\. The expected survival time is \\>=3 months.\n* 7\\. The organ function level and related laboratory indicators must meet requirement.\n* 8\\. Agree to use reliable and effective methods of contraception during the study treatment period and for at least 3 months after the last study treatment.\n\nExclusion Criteria:\n\n* 1\\. Individuals who are known to have severe allergic reaction to the study drug or any other ingredients\u002Fexcipients in the formulation.\n* 2\\. Meets one of the following conditions: patients with brainstem involvement or extracranial metastasis; patients with severe brain herniation or at risk of brain herniation.\n* 3\\. History of other malignant tumors within 3 years or concurrent active malignant tumors.\n* 4\\. The toxic reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade 1.\n* 5\\. Have used potent inhibitors or inducers of CYP3A4, CYP2C19 or CYP1A2 within the 14 days prior to randomization or are still requiring continued use of such agents.\n* 6\\. Individuals currently receiving warfarin or other oral anticoagulants (excluding those who use low-dose anticoagulants to maintain patency of central venous access or prevent deep vein thrombosis).\n* 7\\. Individuals who are unable to undergo enhanced MRI (such as those with pacemakers, metal dentures, claustrophobia, contrast agent allergies, etc.).\n* 8\\. Individuals with evidence or medical history of bleeding tendency within 2 months prior to randomization.\n* 9\\. Individuals with urine protein ≥ 2+, and 24-hour quantitative urine protein ≥ 1.0 g\u002F24 h upon testing.\n* 10\\. History of acquired immunodeficiency syndrome or HIV antibody positivity in the past; Active hepatitis C; Active hepatitis B.\n* 11\\. Individuals with poorly healing wounds or ulcers, or fractures that require treatment or exhibit poor healing.\n* 12\\. Within 14 days prior to randomization, there were severe chronic or active infections (including tuberculosis infections) that required intravenous injection of antibacterial, antifungal or antiviral therapy.\n* 13\\. Individuals with cardiovascular and cerebrovascular diseases of significant clinical significance.\n* 14\\. Have undergone surgery of major vital organs within 28 days prior to randomization (excluding puncture biopsy).\n* 15\\. Individuals with swallowing difficulties or known medication absorption disorders.\n* 16\\. Pregnant or lactating women.\n* 17\\. Any other conditions that may interfere with the participant's adherence to study procedures, compromise the participant's best interests in participating in the study, or affect study results.","ALL","18 Years",{"count":85,"type":86},136,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","This is a randomized, controlled, open-label, multicenter, Phase III clinical study designed to compare the efficacy and safety of SYHA1813 versus treatment of investigators' choice in patients with recurrent or progressive high-grade meningioma not amenable to local therapy.",[92],"High Grade Meningioma","NOT_YET_RECRUITING","2026-05-21",{"date":96,"type":97},"2026-05-29","ACTUAL",{"date":99,"type":86},"2026-05-20",{"date":101,"type":86},"2029-10-15",{"name":5,"class":6}]