This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial, patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival (PFS)
defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy
Time frame: Approximately 1 year
Overall survival (OS)
defined as the time from randomize to death
Time frame: Approximately 3 years
Objective response rate (ORR)
defined as the rate of complete response and partial response according to RECIST guidelines.
Time frame: Approximately 1 year
Disease control rate(DCR)
defined as the rate of complete response , partial response and stable disease according to RECIST guidelines.
Time frame: Approximately 1 year
Quality of life(QoL)
as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Time frame: Approximately 3 years
Safety (incidence of adverse events)
incidence of adverse events
Time frame: Approximately 1 year
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