A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate 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 2 lines of chemotherapy
- Life expectancy of more than 3 months
- ECOG performance scale ≤ 1
- At least one measurable lesion beyond stomach (larger than 10 mm in diameter by
spiral CT 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 (platelets > 80 × 109/L,
neutrophil > 1.5 × 109/L, serum creatinine ≤ 1X upper limit of normal(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 carcinoma
in-situ of uterine cervix
- Any factors that influence the usage of oral administration; Evidence of CNS
metastasis
- Intercurrence with one of the following: uncontrolled hypertension, coronary artery
disease, arrhythmia and heart failure
- INR > 1.5 and APPT > 1.5 X 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.