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

Inclusion Criteria:

• Signed informed consent

• Histologically or cytologically confirmed gastric or gastroesophageal junctionadenocarcinoma

• Metastatic disease or locally advanced, unresectable disease

• Disease progression during or within 4 months after the last dose of the first-linetherapy (with platinum/fluoropyrimidine )

• Adequate hepatic, renal, heart, and hematologic functions

• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

• Willingness and ability to comply with scheduled visits, treatment plans, laboratorytests, and other study procedure

• Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria:

• Pregnant or lactating women

• Any factors that influence the usage of oral administration

• Evidence of CNS metastasis

• Intercurrence with one of the following: non-controlled hypertension, coronaryartery disease, arrhythmia and heart failure

• Abuse of alcohol or drugs

• Less than 4 weeks from the last clinical trial

• Previous treatment with VEGFR inhibition

• Disability of serious uncontrolled intercurrence infection

• Proteinuria ≥ 2+ (1.0g/24hr)

• Have evidence or a history of bleeding tendency within two months of the enrollmentrandomization, regardless of seriousness

• Within 12 months before the first treatment occurs artery/venous thromboembolicevents, such as cerebral vascular accident (including transient ischemic attack)etc.

• Within 6 months before the first treatment occurs acute myocardial infarction, acutecoronary syndrome or CABG

• Bone fracture or wounds that was not cured for a long time

• Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant Therapy

• The tumor invades a large vessel structure, such as the pulmonary artery, superiorvena cava, or inferior vena cava