Title
Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
Phase
Phase 2Lead Sponsor
Simcere Pharmaceutical Co., LtdStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Esophageal CancerIntervention/Treatment
endostatin ...Study Participants
40This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.
75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks
6~15MV X-ray, 2Gy/time,5times/week,6 weeks
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