Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Drug: Endostar; Radiation: Radiotherapy

• 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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-24
• Primary Completion: 2013-05
• Study Completion: 2013-05

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