Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01368419
• Collaborator: The First People's Hospital of Lianyungang (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: Endostar; Radiation: Radiotherapy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
• Study Start Date: May 1, 2011
• Anticipated Primary Completion Date: May 1, 2013
• Anticipated Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment	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

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (ORR) [1 month after treatment]

Secondary Outcome Measures

1. Overall Survival (OS) [2 years]

2. Time to Progression (TTP) [every three months until disease progression]

3. Clinical Benefit Rate (CBR) [1 month after treatment]

4. Serum VEGF Levels [at baseline and 6 weeks]

5. Incidence of Adverse Events [up to 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu	China	222002

Sponsors and Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.
• The First People's Hospital of Lianyungang

Investigators

• Principal Investigator: Xiaodong Jiang, MD, The First People's Hospital of Lianyungang

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01368419
• Other Study ID Numbers: Endu-201105
• First Posted: Jun 8, 2011
• Last Update Posted: Apr 24, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.: Endostar; Radiotherapy; Esophageal Cancer
• Additional relevant MeSH terms: Esophageal Neoplasms; Endostar protein

Study Results

No Results Posted as of Apr 24, 2013