In this study, We investigated the efficacy and safty of camrelizumab combined with S-1 maintenance after first-line induction chemotherapy for GC. Patients without progressive disease after 4-6 weeks of first-line chemotherapy with SOX will be treated with camrelizumab combined with S-1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.
Lin Zhao
Beijing, Beijing Municipality, China
RECRUITINGProgression-Free Survival (PFS)
PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.
Time frame: From the start of randomization to a minimum of 42 months
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 3.5 years
Objective Response Rate(ORR)
Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Time frame: From the start of randomization to a minimum of 42 months
Disease Control Rate (DCR)
Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.
Time frame: Time Frame: From the start of randomization to a minimum of 42 months
Overall Survival(OS)
OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.
Time frame: From the start of randomization to a minimum of 42 months
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