Lung cancer patients with brain metastases
Conditions
Interventions
Bevacizumab group:Since the initiation of SRT, bevacizumab has been administered at a dosage of 2.5 mg/kg via intravenous drip every two weeks, for a maximum of six doses.
The control group :The control group received clinical observation only during SRT.
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.ECOG performance status 0-1; 3.Cytologically or histopathologically confirmed diagnosis of lung cancer (including small cell lung cancer and non-small cell lung cancer); 4.Brain metastases diagnosed by contrast-enhanced MRI, with the largest diameter of brain metastases = 3 cm, and deemed suitable for SRT (stereotactic radiotherapy) as assessed by the investigator; 5.No prior radiotherapy for brain metastases; 6.No treatment with bevacizumab within the past 3 months; 7.No radiologically or clinically confirmed brain injury, such as cerebral edema or radiation necrosis; 8.No significant abnormalities in routine laboratory tests (complete blood count, liver and kidney function, coagulation function, etc.): Hematological criteria (no blood transfusion or blood products within 14 days): a. ANC >= 1.5 × 10^9/L; b. PLT >= 80 × 10^9/L; Biochemical criteria: a. TBIL 45 mL/min (Cockcroft-Gault formula); 9.For patients with reproductive potential, medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study treatment and for 1 month after treatment completion. A negative serum or urine HCG test within 72 hours before enrollment is required, and the patient must be non-lactating; 10.Ability to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Active bleeding or pathological conditions with a high risk of bleeding; 2.Central nervous system hemorrhage or bleeding tendency, abdominal fistula, abscess, or gastrointestinal perforation occurring 140 mmHg and/or diastolic blood pressure [DBP] > 90 mmHg despite antihypertensive therapy); 8.Severe comorbidities, including: History of major cerebrovascular accident (CVA) within 6 months; Myocardial infarction or unstable angina within 6 months; Congestive heart failure of New York Heart Association (NYHA) Class II or higher; Severe and poorly controlled arrhythmia; Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection); Clinically significant peripheral vascular disease; Severe infection; 9.History of allergic reaction to bevacizumab; 10.Pregnancy or intention to become pregnant in women of childbearing age; 11.Other conditions deemed by the investigator as unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade =3 cerebral edema at 3 months after radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Cerebral Necrosis Onset;Incidence of Grade =2 Brain Injury;Incidence of grade =3 cerebral edema at 6months after radiotherapy; | — |
Countries
China
Contacts
Public ContactHui Zhu
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed