This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
HLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w
HLX07 1500mg q3w
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, China
RECRUITINGFudan University shanghai cancer center
Shanghai, China
RECRUITINGORR
Objective response rate by IRRC assessment per RECIST 1.1
Time frame: Up to 2 years
PFS
Progression-free survival by IRRC assessment per RECIST 1.1
Time frame: From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
OS
Overall survival
Time frame: From the date of first dose unitl the date of death from any cause,assessed up to 2 years
ORR
Objective response rate by INV assessment per RECIST 1.1
Time frame: Up to 2 years
PFS
Objective response rate by INV assessment per RECIST 1.1
Time frame: From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
DOR
Duration of response by IRRC/INV assessment per RECIST 1.1
Time frame: From the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years
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