Status:
UNKNOWN
An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Esophagus Cancer, Stage III
Esophageal Gastric Cardia Type Metaplasia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophagea...
Detailed Description
This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by apatinib mesilate.The m...
Eligibility Criteria
Inclusion
- ≥ 18 and ≤ 75 years of age
- Have failed for 1 lines of chemotherapy
- ECOG performance scale 0 - 2.
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min.
- Life expectancy of more than 12 months
Exclusion
- Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Any factors that influence the usage of oral administration
- The center of the tumor invaded local large blood vessels
- Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
- Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
- Less than 4 weeks from the last clinical trial
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03285906
Start Date
March 1 2017
End Date
December 1 2019
Last Update
September 18 2017
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060