This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.
Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.
Aged between 18 and 75 years inclusive, male or female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Estimated survival expectancy ≥ 12 weeks.
Received systemic anti-tumor therapies (including investigational agents) or major surgery within 4 weeks prior to the first study drug administration; palliative radiotherapy within 2 weeks or surgery within 4 weeks before study treatment initiation.
History of hypersensitivity to monoclonal antibodies or any component of the investigational products to be administered in this study.
Pre-existing peripheral neuropathy of Grade >1.
History of thromboembolic disease within 6 months or hemoptysis within 3 months before first study medication. Subjects with muscular venous thrombosis not requiring anticoagulation per investigator's assessment are eligible for enrollment.
Parallel
SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
DrugSHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
DrugOxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)
Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)
Duration of Response (DoR) assessed by Independent Review Committee (IRC)
Progression-Free Survival (PFS) assessed by the Investigator
Objective Response Rate (ORR) assessed by the Investigator
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