[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639075":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":25,"enrollmentInfo":46,"targetDuration":25,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":25,"overallStatus":55,"whyStopped":25,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":25},{"fullName":5,"class":6},"Shanghai Runshi Pharmaceutical Technology Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","SYHA1813",[13],"Drug: SYHA1813",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Investigator's Choice Treatment",[19],"Drug: Investigator's Choice Treatment",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","SYHA1813 20mg QD",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Investigator's Choice Treatment：bevacizumab, temozolomide or hydroxyurea",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100639075","phase-3-a-phase-iii-study-of-syha1813-for-recurrent-or-progressive-high-grade-meningiomas-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":47,"type":48},136,"ESTIMATED","INTERVENTIONAL",[51],"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.",[54],"High Grade Meningioma","NOT_YET_RECRUITING","2026-05-21",{"date":58,"type":59},"2026-05-29","ACTUAL",{"date":61,"type":48},"2026-05-20",{"date":63,"type":48},"2029-10-15",{"name":5,"class":6}]