A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

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 insolid tumors (RECIST v1.1);

• Patients must have received one prior chemotherapy regimen for AGC;First-line therapymust have included a combination of at least a platinum-based treatment givenconcurrently, and must have experienced disease progression during or after first-linetherapy 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, Morethan 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, totalbilirubin ≤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 carcinomainsitu 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 heartfailure;

• 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 antiangiogenesis therapy;

• Evidence of central nervous system(CNS) metastasis;

• Disability of serious uncontrolled intercurrence infection.