benign metastatic leiomyoma
Conditions
Interventions
intervention group:oral sirolimus
observation group:Outpatient follow-up
Sponsors
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: i. Agree and sign and date the informed consent form; ii. At least 18 years old at the time of outpatient or inpatient treatment at Peking Union Medical College Hospital; iii. Patients diagnosed with benign metastatic leiomyomatosis by imaging or pathology at the time of screening; iv. Evidence of good health based on medical history, physical examination, and laboratory test results. v. Use effective non-hormonal contraceptive methods (various barrier contraceptive methods, etc.) from the beginning of screening until the end of the study. If the subject is already using a permanent method of contraception (tubal ligation or partner's vasectomy), no barrier method is required.
Exclusion criteria
Exclusion criteria: i. Refusal to sign the informed consent form; ii. Hypersensitivity to the study drug; iii. Severe liver and kidney dysfunction or abnormal lipid metabolism: AST>2.5×upper limit of normal (ULN), ALT>2.5×upper limit of normal (ULN), serum total bilirubin>1.5×upper limit of normal (ULN), creatinine > 1.5 x upper limit of normal (ULN); iv. Severe pulmonary function abnormalities require immediate surgical treatment; v. Patients who need to take the following drugs (cyclosporine, erythromycin, ketoconazole, rifampicin, verapamil, bromocriptine, etc.) due to other diseases and cannot stop taking the drugs; vi. Participate in other drug research at the same time; vii. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactFan Rong
Beijing Union Medical College Hospital
Outcome results
None listed