This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W). In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.
HLX22 15mg/kg Q3w
Pembrolizumab 200mg q3w
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Oxaliplatin 130 mg/m2 ,Q3W
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Buenos Aires, Buenos Aires, Argentina
Puerto Alegre, RS, Argentina
Viedma, Río Negro Province, Argentina
Cordoba, Santa Fe Province, Argentina
Cordoba, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
San Pablo, SP, Argentina
Buenos Aires, Argentina
Córdoba, Argentina
San Juan, Argentina
San Juan, Argentina
San Miguel de Tucumán, Argentina