Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Inclusion Criteria:

• ≥ 18 and ≤ 70 years of age

• Histological confirmed advanced or metastatic adenocarcinoma of the stomach

• Have failed for at least 2 lines of chemotherapy

• Life expectancy of at least 12 weeks.

• Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week beforerandomization.

• At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiralCT scan)

• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin

• More than 4 weeks for operation or radiotherapy

• More than 4 weeks for cytotoxic agents or growth inhibitors

• Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit ofnormal(ULN), bilirubin < 1.25× 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 carcinomain-situ of uterine cervix Hypertension and unable to be controlled within normal levelfollowing treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg,diastolic blood pressure > 90 mmHg).

• Any factors that influence the usage of oral administration; Evidence of CentralNerves System(CNS) metastasis

• Intercurrence with one of the following: coronary artery disease, arrhythmia ,heartfailure and proteinuria ≥ (+)

• International Normalize Ratio (INR) > 1.5 and activated partial thromboplastintime（APPT） > 1.5 × ULN

• Abuse of alcohol or drugs

• Certain possibility of gastric or intestine hemorrhage

• Less than 4 weeks from the last clinical trial

• Prior VEGFR inhibitor treatment

• Disability of serious uncontrolled intercurrence infection Objective evidence ofprevious or current pulmonary fibrosis history, interstitial pneumonia,Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary functiondamaged seriously etc.