The study is a multicenter, open-label, randomized controlled clinical study. The purpose of the study is to evaluate the efficacy and safety of apatinib combined with chemotherapy versus chemotherapy in second-line gastric cancer receiving prior anti-PD-1 therapy.
60 patients who meet the inclusion criteria will receive apatinib combine with chemotherapy or chemotherapy until the disease progresses or intolerable. Apatinib: initial dose: 500mg,oral,once a day, after meal (try to take the medicine at the same time each day)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
In experimental group, the drug used with apatinib and chemotherapy.
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Progression Free Survival [PFS]
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Time frame: 36 months
Objective tumor response rate [ORR]
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
Time frame: 1year
disease control rate [DCR]
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)
Time frame: 1year
Duration of response [DoR]
Duration of response
Time frame: 1year
overall survival [OS]
OS is defined as the length of time from random assignment to death or to last contact.
Time frame: 3year
Adverse Events [AEs]
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Time frame: 1year
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