The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,004
Apatinib Tablets, recommended dose of 850mg
Nanjin Military 81 Hosiptal
Nanjing, Jiangsu, China
Fudan University cancer hospital
Shanghai, Shanghai Municipality, China
Safety, which was assessed by recording the incidence and severity of adverse events
Time frame: between first dose of apatinib and up to 30 days after the last dose of apatinib
Overall Survival
Time frame: Event driven, an expected average of 34 weeks
Progression Free Survival
Time frame: An expected average of 12 weeks
Objective Response Rate
Time frame: An expected average of 12 weeks
Disease Control Rate
Time frame: An expected average of 12 weeks
Quality of life, measured by the questionnaire of EORTC QLQ-C30
Time frame: Quality of life will be assessed at baseline (after the patients provided written informed consent) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks
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