Investigators assessed the effectiveness of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
HLX10 4.5mg/kg, IV, q3weeks, Day 1 trastuzumab 6mg/kg (8mg loading dose), IV, q3weeks, Day 1 S1 40mg/m2, PO, BID, Day 1-14 oxaliplatin 100mg/m2, IV, q3weeks, Day 1 docetaxel 40mg/m2, IV, q3weeks, Day 1
Progression-free survival
Progression-free survival in patients with HER2-positive gastric cancer receiving HLX10, trastuzumab, and chemotherapy combination treatment
Time frame: 18 months after start of treatment
Overall survival
Overall survival
Time frame: through study completion, an average of 2 years
Objective response rate according to RECIST 1.1
Objective response rate according to RECIST 1.1
Time frame: through study completion, an average of 2 years
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
Time frame: Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject
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