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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01368419
Other study ID # Endu-201105
Secondary ID
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


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
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