Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01368419 |
Recruitment Status
: Unknown
Verified April 2013 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted
: June 8, 2011
Last Update Posted
: April 24, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Cancer | Drug: Endostar Radiation: Radiotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
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 2011 |
Estimated Primary Completion Date : | May 2013 |
Estimated Study Completion Date : | May 2013 |

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
|
- Objective Response Rate (ORR) [ Time Frame: 1 month after treatment ]
- Overall Survival (OS) [ Time Frame: 2 years ]
- Time to Progression (TTP) [ Time Frame: every three months until disease progression ]
- Clinical Benefit Rate (CBR) [ Time Frame: 1 month after treatment ]
- Serum VEGF Levels [ Time Frame: at baseline and 6 weeks ]
- Incidence of Adverse Events [ Time Frame: up to 3 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368419
Contact: Xiaodong Jiang, MD | 86-0518-85605120 |
China, Jiangsu | |
The First People's Hospital of Lianyungang | Recruiting |
Lianyungang, Jiangsu, China, 222002 | |
Contact: Xiaodong Jiang, MD 0518-85605120 | |
Principal Investigator: Xiaodong Jiang, MD |
Principal Investigator: | Xiaodong Jiang, MD | The First People's Hospital of Lianyungang |
Responsible Party: | Jiangsu Simcere Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01368419 History of Changes |
Other Study ID Numbers: |
Endu-201105 |
First Posted: | June 8, 2011 Key Record Dates |
Last Update Posted: | April 24, 2013 |
Last Verified: | April 2013 |
Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Endostar Radiotherapy Esophageal Cancer |
Additional relevant MeSH terms:
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |