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.
1. Aged >= 18 years.
2. Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th) that is progressive or recurrent.
3. Individuals must have received surgery and radiation therapy.
4. There is at least one measurable intracranial tumor lesion in the baseline period (RANO-meningioma).
1. Individuals who are known to have severe allergic reaction to the study drug or any other ingredients/excipients in the formulation.
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.
3. History of other malignant tumors within 3 years or concurrent active malignant tumors.
4. The toxic reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade 1.
Parallel
SYHA1813
DrugSYHA1813 20mg QD
Investigator's Choice Treatment
DrugInvestigator's Choice Treatment：bevacizumab, temozolomide or hydroxyurea
Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC
PFS as Assessed by RANO Criteria and Evaluated by investigators
Overall Survival (OS)
Overall Survival Rate at 12 Months (OS-12)
Progression Free Survival Rate at 6 Months (PFS-6) as Assessed by RANO Criteria
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This trial is not recruiting at the moment. You can still explore other options:
