Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
Phase 2
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Cancer
Both
Esophageal Cancer
Trial Information
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate (ORR)
Outcome Time Frame:
1 month after treatment
Safety Issue:
No
Principal Investigator
Xiaodong Jiang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The First People's Hospital of Lianyungang
Authority:
China:SFDA
Study ID:
Endu-201105
NCT ID:
NCT01368419
Start Date:
May 2011
Completion Date:
May 2013
Related Keywords:
- Esophageal Cancer
- Endostar
- Radiotherapy
- Esophageal Cancer
- Esophageal Diseases
- Esophageal Neoplasms
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