MRG003与化疗在患者治疗中的随机对照研究

Eligible patients were randomly assigned in a 1:1 ratio to receive either MRG003 or chemotherapy using a stratified block randomization method. The chemotherapy group received either capecitabine or docetaxel, as chosen by the investigator. Stratification factors included liver metastasis (yes vs. no) and ECOG PS (0 vs. 1), with a dynamic random block size of 2, 4, or 6. The dose of MRG003 was 2.3 mg/kg on day 1, administered intravenously every 3 weeks (Q3W). Capecitabine was dosed at 1000 mg/m² twice daily (bid) on days 1-14, administered orally every 3 weeks (Q3W). Docetaxel was dosed at 75 mg/m² on day 1, administered intravenously every 3 weeks (Q3W). The dose of MRG003 could be adjusted to 2.0 mg/kg or 1.5 mg/kg based on tolerability (specific adjustment criteria are detailed in the protocol). Treatment continued until disease progression, intolerable toxicity related to the study drug, withdrawal of informed consent, or termination of treatment for any reason. Patients in the control group who experienced disease progression could cross over to receive MRG003 treatment. Tumor assessments were conducted every 6 weeks during the first 6 treatment cycles, then every 8 weeks during subsequent treatment periods, and every 12 weeks after treatment completion. Safety follow-up was conducted up to 45 days after the last dose or until the start of other anti-tumor therapy, whichever occurred first.