About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
- Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab