Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
- Registration Number
- NCT01368419
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief Summary
This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer
- Measurable disease according to RECIST criteria
- ECOG Performance Status 0-1
- The length of esophageal carcinoma ≤ 10 cm
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
- Renal function: Cr ≤ 2.0×UNL
- Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL
Exclusion Criteria
- Pregnant or lactating women
- Evidence of bleeding diathesis, 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Radiotherapy - Treatment Endostar -
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 1 month after treatment
- Secondary Outcome Measures
Name Time Method Serum VEGF Levels at baseline and 6 weeks Incidence of Adverse Events up to 3 months Clinical Benefit Rate (CBR) 1 month after treatment Overall Survival (OS) 2 years Time to Progression (TTP) every three months until disease progression
Trial Locations
- Locations (1)
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China