Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Endostar, Radiotherapy, Esophageal Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endostar Type: Drug
Name: Radiotherapy Type: Radiation
Overall Status
Recruiting
Summary
This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Status: Recruiting
Contact: Xiaodong Jiang, MD - 0518-85605120
Start Date
May 2011
Completion Date
May 2013
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Source
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page