Brain edema following gamma knife radiotherapy of brain metastases
Conditions
Interventions
experimental group:Bevacizumab + mannitol + dexamethasone
Control group:Mannitol + dexamethasone
Sponsors
Xi'an International Medical Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent before participating in the study; 2. Understand the importance of complying with study medication regulations and completing assessments on time throughout the study, and agree to strictly abide by protocol regulations, including restrictions on concomitant medication during the study; 3. Age >=18 years old and =12 months; 9. Must have metabolic organ and bone marrow hematopoietic function that can withstand study treatment, as defined below: Blood routine: white blood cell count >=1.5 × 10^9/L, platelet count >= 100× 10^9/L, hemoglobin >= 90g/L Coagulation function: International normalized ratio (INR), prothrombin time (PT), and partial thromboplastin time (APTT) within normal values Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 50 mL/min;
Exclusion criteria
Exclusion criteria: 1. Those at risk of bleeding, including but not limited to: Tumors invade major blood vessels (e.g., carotid arteries), trachea, esophagus, and patients with sinus tract formation Presence of a history of bleeding related to tumor or radiotherapy during or after the end of radiotherapy Presence of active central nervous system bleeding; 2. Those with gastrointestinal perforation, gastrointestinal fistula, intra-abdominal abscess and non-gastrointestinal fistula (such as tracheo-esophageal fistula) within 6 months before screening; 3. Persistent wound dehiscence and wound healing complications requiring intervention at screening; 4. Subjects with hypertensive crisis or hypertensive encephalopathy, or poorly controlled hypertension (defined as systolic blood pressure (SBP) >= 150 mmHg and/or diastolic blood pressure (DBP) >= 100 mmHg despite taking antihypertensive medications); 5. Serious cardiovascular and cerebrovascular and systemic complications at screening: 1) history of large vessel cerebrovascular accident within 6 months, 2) myocardial infarction or unstable angina within 6 months, 3) New York Heart Association class II or above congestive heart failure, 4) severe and inadequately controlled arrhythmia, 5) major vascular disease (such as aortic aneurysm, history of aortic dissection, CTCAE>). =Grade 3 venous thromboembolism), 6) clinically significant peripheral vascular disease, 7) severe infection, 8) nephrotic syndrome or routine presence of moderate to severe proteinuria (24-hour urine protein >2g), 9) reversible posterior encephalopathy syndrome (PRES); 6. Patients with any evidence or clinically significant adverse physical condition or abnormal examination (physical examination, vital signs, ECG or laboratory test abnormalities, etc.) that may affect patient safety or evaluation of study endpoints in the opinion of the investigator; 7. Those who are allergic to bevacizumab (including any component of the product and Chinese hamster ovarian cell products or other recombinant human or humanized antibodies); 8. Patients with a history of alcohol, drug or chemical abuse, which the investigator judges may harm or affect the patient's complete participation in this study; 9. Pregnant or lactating women; 10. Women and men of childbearing age who are unwilling to use highly effective contraceptive methods during the study or for at least 3 months after taking the test drug for the last time; Highly effective contraceptive methods for female patients include: - Total abstinence Surgical sterilization of women (bilateral oophorectomy, total hysterectomy, or tubal ligation with or without hysterectomy) at least 6 weeks prior to receiving study treatment - Male sterile (at least 6 months prior to screening), for female patients on study, the vasectomized male partner should be the sole partner for that patient - Use of oral contraceptives (estrogen and progesterone), and female patients should be on stable use of the same contraceptive for at least 3 months prior to receiving study treatment - Injected or implanted hormonal contraceptive method or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception with similar efficacy (failure rate <1%), such as hormonal vaginal ring or transdermal hormonal contraception Highly effective contraceptive methods for male patients include: - Vasectomy (with post-vasectomy documentation proving the absence of sperm in ejaculation) - Sexual int
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in lesion volume (T2-weighted FLAIR images);incidence of adverse events; | — |
Countries
China
Contacts
Public ContactMingsheng Chen
Xi'an International Medical Center Hospital
Outcome results
None listed