Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial

Inclusion Criteria:

1. Age 18-65 years, any gender;

2. Patients who have experienced their first symptomatic BSCM ICH within the six monthsbefore randomisation;

3. Diagnosed with solitary BSCM through T2, GRE/T2*, or SWI MR imaging;

4. ICH within or around the BSCM confirmed by CT /MR;

5. Capable of signing an informed consent form with the accompaniment and understandingof a guardian.

Exclusion Criteria:

1. Cancer history;

2. Pregnancy or lactation;

3. Sirolimus/starch allergy;

4. Modified Rankin Scale (mRS) score 5, respiratory failure or currently severebleeding requiring life support treatment;

5. Abnormal liver and/or kidney function (transaminase levels greater than 50,creatinine greater than 110), abnormal white blood cell/platelet counts (white bloodcell count below 3.5 or above 9.5 x 109/L or exceeding normal values, platelet countbelow 100 or above 300);

6. History of previous immunosuppressive therapy;

7. History of prior surgical intervention for CCM ;

8. History of prior cranial radiation therapy ;

9. Familial CCM or people with multiple CCM;

10. Patients with concurrent acute active infections (e.g., severe bacterial, viral, orfungal infections);

11. Uncontrolled diabetes mellitus;

12. Currently participating in another clinical trial;

13. Patient unwilling/unable to undergo MRI.

14. Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole,itraconazole, telithromycin, clarithromycin).