Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
267
The 81 Hosiptal of PLA
Nanjing, Jiangsu, China
Fudan University cancer hospital
Shanghai, Shanghai Municipality, China
Progression Free Survival(PFS)
Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: 30 months
Overall Survival(OS)
Overall Survival of the Participants
Time frame: 30 months
Disease Control Rate(DCR)
Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.
Time frame: 30 months
Objective Response Rate(ORR)
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)
Time frame: 30 months
Percentage of Participants With Adverse Events
Time frame: 30 months
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