1. Intracranial tumors: mainly meningioma and glioma
Conditions
Interventions
Intervention group:Oral administration
Sponsors
SUN YAT-SEN MEMORIAL HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age =18 years; 2.According to the NF1 diagnostic criteria updated by the National Institutes of Health (NIH) in 2021, the diagnosis was NF1; 3.Before admission, the head and neck surgeon conducted pathological biopsy of solid tumor, confirmed pathological diagnosis and eliminated malignant peripheral schwannoma (MPNST). 4.There was at least one measurable tumor lesion according to the solid tumor response evaluation criteria RECIST 1.1; 5.The tumor did not invade the brain, spine and other important organs, there are indications of surgical resection and surgical treatment; 6.The Eastern Cooperative Oncology Group (ECOG) had a performance status of 0-1; 7.Blood routine: White blood cell count (WBC) =3.0×109/L; Absolute neutrophil count (ANC) = 1.5×109/L; Platelet (PLT) = 100×109/L; Hemoglobin level (HGB) = 9.0 g/dL (no corresponding supportive treatment within 7 days, such as blood transfusion and increased white blood cells); 8.Liver function: The patient's aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were less than 2.5 times the upper limit of reference value (ULN); Albumin (ALB) = 30 g/L; 9.Renal function: serum creatinine =1.5 times ULN or creatinine clearance (CrCl) = 50mL/min (using Cockcroft/Gault formula); Urinary protein (UPRO) < (++), or 24-hour urinary protein volume < 1.0 g; 10.Cardiac function: creatine phosphokinase =200U/L, left ventricular ejection fraction (LVEF) =50%; 11.Have not participated in other clinical trials within 30 days; 12.Patients who volunteer to participate in the program and sign informed consent;
Exclusion criteria
Exclusion criteria: 1.The patient had abnormal blood indexes and abnormal liver, kidney and heart function, and could not tolerate the clinical study process after multidisciplinary consultation and evaluation; 2.Patients have malignant peripheral schwannoma (MPNST) or other malignant tumors, heart disease and other serious complications, or have previously received chemotherapy, radiotherapy and other anti-tumor therapy; 3.Unable to complete the entire clinical study due to personal, social, and economic reasons; 4.Have a prior serious systemic disease that cannot be cured or controlled by medicine; 5.Pregnant patient;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactHuang Zhiquan
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed