Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases

The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.

Inclusion Criteria:

• Histologically confirmed malignancy with presence of intraparenchymal brain metastases
• Karnofsky performance status ≥ 40
• Measurable disease according to RECIST criteria
• Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
• Renal function: Cr ≤ 2.0×ULN
• Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN
• Adequate cardiac function
• Life expectancy ≥ 3 months

Exclusion Criteria:

• Evidence of bleeding diathesis or serious infection
• Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
• Uncontrollable mental and nervous disorders
• Pregnant or lactating women