Malignant tumor
Conditions
Interventions
Observation group:None
Sponsors
BEIJING LUHE HOSPITAL CAPITAL MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Malignant tumors with confirmed pathological or cytological diagnosis of primary malignancy; 2.Brain metastasis diagnosed by contrast-enhanced brain MRI, with more than 1 metastatic brain lesion, or maximum lesion diameter = 3 cm, or lesion volume = 6 cm³; 3.Aged 18 to 75 years, with no gender restriction. 4.KPS = 60, or KPS = 20 with dysfunction solely attributable to intracranial tumor, and expected survival exceeding 3 months. 5.No severe abnormalities in hematopoietic function, cardiac, pulmonary, hepatic or renal function, and no immunodeficiency. Laboratory results must meet the following criteria: hemoglobin = 90 g/L; absolute neutrophil count = 1.5×10?/L or white blood cell count = 3.0×10?/L; platelet count = 100×10?/L; aspartate aminotransferase (AST) = 2.5×ULN; alanine aminotransferase (ALT) = 2.5×ULN; total bilirubin = 1.5×ULN; serum creatinine = 1.0×ULN. 6.Have a full understanding of the study, possess the ability to complete the treatment, have access to follow-up conditions, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Other reasons deemed by the investigator to render the patient ineligible for this study, including small cell lung cancer, melanoma, lymphoma and other hematological malignancies. 2.Extensive meningeal metastasis or leptomeningeal metastasis; 3.Complicated with uncontrolled, life-threatening severe medical comorbidities, such as acute myocardial infarction, cerebral infarction, severe diabetic complications, severe infection, psychiatric disorders, etc. 4.Received brain radiotherapy within 1 year. 5.Pregnant or lactating individuals. 6.Refusal or inability to sign the informed consent form for study participation. 7.Any other conditions deemed by the investigator to render the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year intracranial objective response rate (iORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);1-year intracranial objective response rate (iORR);1-year and 2-year intracranial progression-free survival (iPFS);Incidence of radiation-induced brain necrosis; | — |
Countries
China
Contacts
Public ContactYuyan Gao
BEIJING LUHE HOSPITAL CAPITAL MEDICAL UNIVERSITY
Outcome results
None listed