Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer

Inclusion Criteria:

1. Age≥18 years;

2. Pathologically diagnosed with advanced gastric adenocarcinoma (includinggastroesophageal junction) with measurable metastases outside the stomach (≥10mm onspiral CT scan, and meet the criteria of Response Evaluation Criteria in Solid Tumors 1.1);

3. Locally advanced, recurrent or metastatic gastric or gastro-oesophageal junctionadenocarcinoma;

4. Finished first-line chemotherapy (fluorouracil combined with oxaliplatin, cisplatin,paclitaxel or docetaxel) 3 weeks a cycle for 4 cycles, of which the last efficacyassessment is SD, PR or CR. No more than 28 days from the starting day of last cycleof chemotherapy;

5. Eastern Cooperative Oncology Group（ECOG）performance status 0 or 1;

6. Blood routine test and Biochemical tests:

• Hemoglobin ≥ 80g / L;

• Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;

• Platelet count≥ 90 × 109 / L;

• Alanine aminotransferase (ALT)and Aspartate aminotransferase (AST) <2.5× upperlimit of normal (ULN); liver metastases, if any, the ALT and AST<5 × ULN;

• Serum total bilirubin≤1.5 × ULN;

• Serum creatinine≤1.5 × ULN;

• Serum albumin≥30g/L;

7. Life expectancy more than 3 months;

8. Voluntarily join the study and sign the Informed Consent Form for the study;

9. Pregnancy test (serum or urine) has to be performed for woman of childbearing agewithin 7 days before enrolment and the test result must be negative. They shall takeappropriate methods for contraception during the study until the 8th week post thelast administration of study drug. For men, (previous surgical sterilizationaccepted), shall agree to take appropriate methods of contraception during the studyuntil the 8th week post the last administration of study drug.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributedto apatinib or its accessories;

2. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHgand diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronaryheart disease greater than ClassⅠ; Ⅰ-level arrhythmia (including QT intervalprolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰcardiacdysfunction; Patients with positive urinary protein;

3. Factors that could have an effect on oral medication (such as inability to swallow,chronic diarrhea and intestinal obstruction);

4. Subjects with high gastrointestinal bleeding risk, including the following conditions:local active ulcer lesions with positive fecal occult blood test (++); history ofblack stool, or haematemesis in the past 2 months;primary lesion in stomach withpositive fecal occult blood test (+) should be evaluated by endoscopy and otherpotential massive haemorrhage conditions evaluated by the investigator;

5. Abnormal Coagulation (international normalized ratio>1.5, activated partialthromboplastin time>1.5 UNL), with tendency of bleeding;

6. Associated with central nervous system (CNS) metastases;

7. Pregnant or lactating women;

8. Suffering from other malignancies within 5 years;

9. History of uncontrolled psychotropic drug abuse or mental disorders;

10. Participated in other clinical study within 4 weeks;

11. Prior VEGFR inhibitor treatment,such as sorafenib and sunitinib ;

12. Concomitant disease conditions judged by investigator that may seriously affectsubject's safety or affect the study completion;

13. Other cases that the researcher found ineligible