Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborator: The First People's Hospital of Lianyungang
• Treatments: Endostar protein

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