A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric Cancer(FRUTIGA)

Inclusion Criteria:

1. Signed informed consent
2. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
3. Metastatic disease or locally advanced, unresectable disease
4. Disease progression during or within 4 months after the last dose of the first-line therapy (with platinum/fluoropyrimidine )
5. Adequate hepatic, renal, heart, and hematologic functions
6. At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
8. Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria:

1. Pregnant or lactating women
2. Any factors that influence the usage of oral administration
3. Evidence of CNS metastasis
4. Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
5. Abuse of alcohol or drugs
6. Less than 4 weeks from the last clinical trial
7. Previous treatment with VEGFR inhibition
8. Disability of serious uncontrolled intercurrence infection
9. Proteinuria ≥ 2+ (1.0g/24hr)
10. Have evidence or a history of bleeding tendency within two months of the enrollment randomization, regardless of seriousness
11. Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
12. Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
13. Bone fracture or wounds that was not cured for a long time
14. Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant Therapy
15. The tumor invades a large vessel structure, such as the pulmonary artery, superior vena cava, or inferior vena cava