Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Esophageal Cancer Clinical Trial

Official title:

Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01368419
• Other study ID #: Endu-201105
• Status: Recruiting
• Phase: Phase 2
• First received: June 1, 2011
• Last updated: April 22, 2013
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: April 2013
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Xiaodong Jiang, MD
• Phone: 86-0518-85605120
• Is FDA regulated: No
• Health authority: China:SFDA
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Endostar
75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks

Radiation:
• Radiotherapy
6~15MV X-ray, 2Gy/time,5times/week,6 weeks

Locations

Country	Name	City	State
China	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.	The First People's Hospital of Lianyungang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		1 month after treatment	No
Secondary	Overall Survival (OS)		2 years	No
Secondary	Time to Progression (TTP)		every three months until disease progression	No
Secondary	Clinical Benefit Rate (CBR)		1 month after treatment	No
Secondary	Serum VEGF Levels		at baseline and 6 weeks	No
Secondary	Incidence of Adverse Events		up to 3 months	Yes