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The safety and effectiveness of rapamycin (sirolimus) in the treatment of cerebral cavernous malformation

A single-center, randomized, crossover, exploratory clinical study to evaluate the safety and effectiveness of rapamycin (sirolimus) in the treatment of cerebral cavernous malformation

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043189
Enrollment
Unknown
Registered
2021-02-08
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral cavernous malformation

Interventions

A group:phase I: rapamycin capsule 1mg/m2 qd po
phase II: blank control
B group:phase I: blank control
phase II: rapamycin capsule 1mg/m2 qd po

Sponsors

The first hospital of Yichang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged over 18 years; 2. Patients with cerebral cavernous angiomatosis confirmed by nerve biopsy or MRI; 3. Subjects with Karnofsky performance status of 70 or above. 4. Volunteers who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute and chronic infection; 2. Patients with liver, kidney and bone marrow dysfunction; 3. Neutrophils < 1.0 x 10^9 / L; 4. Subjects allergic to rapamycin; 5. Pregnant and lactating women; 6. Liver transplantation and lung transplantation; 7. Patients with severe hyperlipidemia; 8. Subjects who abuse alcohol, drugs or drugs (for example, laxatives); 9. Patients who participate in another clinical trial that may affect the purpose of this study at the same time or within one month; 10. Subjects who had used rapamycin in the past one month; 11. Subjects with a history of major surgery in the past 12 weeks; 12. Subjects with a history of live vaccination 4 weeks ago; 13. Subjects with secondary cerebral hemorrhage; 14. Subjects considered unsuitable for clinical trials for other reasons by researchers; 15. The subjects were willing to treat cerebral cavernous hemangioma by surgery or radiotherapy within one year.

Design outcomes

Primary

MeasureTime frame
Volume changes in cerebral cavernous malformation;

Secondary

MeasureTime frame
Blood concentration of rapamycin;Quality of life scale score;

Countries

China

Contacts

Public ContactJun Wei

The First Hospital of Yichang

junwei@ctgu.edu.cn+86 15090922368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026