An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophagea… (NCT03285906) | Clinical Trial Compass
UnknownPhase 2/3
An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric
China30 participantsStarted 2017-03-01
Plain-language 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 esophageal and gastric
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* ≥ 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 Criteria:
* 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
What they're measuring
1
progression-free survival
Timeframe: Through study completion, an average of 1 year
Trial details
NCT IDNCT03285906
SponsorTianjin Medical University Cancer Institute and Hospital