A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma

Inclusion Criteria:

1. Aged >= 18 years;

2. Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th)

3. There is at least one measurable lesion in the baseline period (RANO-meningioma);

4. KPS≥60;

5. The expected survival time is >=3 months;

6. The organ function level and related laboratory indicators must meet requirements (no blood transfusion within 2 weeks):

7. Female participants of childbearing potential must have a negative the bloodpregnancy test results of within 7 days prior to randomization and agree to usereliable and effective contraception during the study treatment period and for atleast 3 months after the last study treatment (or as required by the drug'sinstructions). Male participants with partners of childbearing potential must agreeto use reliable and effective contraception during the study treatment period andfor at least 3 months after the last study treatment (or as required by the drug'sinstructions).

Exclusion Criteria:

1. Patients who are known or suspected to be allergic to the test drug or itscomponents;

2. Meets one of the following conditions: patients with brainstem involvement; patientswith severe brain herniation or at risk of brain herniation; patients withextracranial metastasis during the screening period.

3. A history of any other malignant tumors within 3 years (except for effectivelycontrolled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficialbladder cancer or cured carcinoma in situ);

4. Use of glucocorticoids at an equivalent dose exceeding 5mg of dexamethasone within 7days prior to randomization.

5. The toxicity of previous anti-tumor treatments has not recovered to Grade1(includingbrain edema after radiotherapy), with the exception of hair loss, uncomplicatedlaboratory abnormalities that do not require medical intervention, and other adversereactions deemed by the investigator not to affect the safety of the studymedication.;

6. Use of a strong CYP3A4 inhibitor within 14 days prior to randomization or ongoinguse of such inhibitors.

7. Current use of warfarin or other oral anticoagulants (except for low-doseanticoagulants used to maintain central venous access or prevent deep veinthrombosis).

8. Inability to undergo contrast-enhanced MRI

9. Patients with evidence of bleeding tendency or medical history within 2 moths

10. Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g/24h;

11. Human immunodeficiency virus (HIV) antibody positive; active hepatitis C (anti-HCVantibody positive and HCV RNA test positive); active hepatitis B (HBV DNA test forHBsAg is positive and HBV DNA is equal to or higher than 2×10^3 IU/ml));

12. The subject has poorly healed wounds, ulcers or fractures;

13. Presence of a severe chronic or active infection (including tuberculosis and otherinfections).requiring intravenous antibiotic, antifungal, or antiviral treatmentwithin 14 days prior to randomization

14. Other severe systemic diseases, including but not limited to uncontrolled diabetes,kidney disease requiring dialysis, severe liver disease (Child-Pugh class B or C),acute pancreatitis, etc.

15. Subjects with clinically significant cardiovascular and cerebrovascular diseases.

16. Underwent major organ surgery within 28 days prior to randomization (excludingbiopsy procedures).

17. Received chemotherapy (including temozolomide), targeted therapy, immunotherapy,hormone therapy, or other antitumor treatments within 28 days prior torandomization; or used any NMPA-approved traditional Chinese medicine or patentChinese medicine with anticancer activity within 14 days prior to randomization (regardless of cancer type).

18. Subjects with dysphagia or known drug absorption disorders.

19. Pregnant or lactating women.

20. Presence of other conditions that may interfere with the participant's ability tocomply with the study procedures or that may not allow the participant to derive themaximum benefit from the study, or that may affect the study outcomes, such as ahistory of psychiatric disorders, drug or substance abuse, or any other clinicallysignificant disease or condition.