Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
- Registration Number
- NCT01410370
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment 6MV-X ray Radiotherapy plus Endostar control 6MV-X ray Radiotherapy treatment Endostar Radiotherapy plus Endostar
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 1 month after initial treatment
- Secondary Outcome Measures
Name Time Method Overall Survival 2 year Serum VEGF Levels at baseline and 1 month after initial treatment VEGF levels in tumor tissue at baseline and 1 month after initial treatment Incidence of Adverse Events up to 1 month after last dose Cerebral Edema 1 month after initial treatment
Trial Locations
- Locations (1)
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China