A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Apr 3, 2015

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Adult patients, aged ≥18 years;
• • Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
• • At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);
• • Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
• • Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
• • Life expectancy of more than 3 months;
• • Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
• • Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 109/L, neutrophil ≥1.5 × 109/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
• Exclusion Criteria:
• • Pregnant or lactating women;
• • History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
• • Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); Uncontrolled hypertension;
• • Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
• • Urine protein\>grade 1;
• • Any factors that influence the usage of oral administration;
• • patients with a clear tendency of gastrointestinal bleeding;
• • Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
• • Abuse of alcohol or drugs;
• • Less than 4 weeks from the last clinical trial;
• • Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
• • Evidence of central nervous system(CNS) metastasis;
• • Disability of serious uncontrolled intercurrence infection.