Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

Exclusion Criteria

• •1. Subjects on systemic therapy with corticosteroid (\> 10 mg daily equivalent of prednisone) or other immunosuppressive agents, except for local inflammation and the prevention of allergy and nausea and vomiting, who had undergone major surgery or severe trauma within 4 weeks prior to the first corticosteroid of the study drug, or who required elective surgery during the trial, who had undergone minor traumatic surgery, such as needle biopsy, within 7 days prior to the first dose of the study drug;
• •2. Previous allergies to monoclonal antibody, formulation components of SHR-A1811 products, and fluorouracil medications;
• •4. Subjects with a history of meningeal metastasis or current meningeal metastasis; active brain metastasis;
• •5. uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• •6. history of immunodeficiency, these included people who tested positive for HIV or who had a fever of \> 38.5 degrees of unknown cause before the first dose (cancer fever, as judged by the researchers, could be enrolled); Severe infection (CTCAE \> Grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. Baseline chest imaging showed active pulmonary inflammation, active hepatitis B (HBV DNA ≥500 IU/mL) and hepatitis C (HCV-RNA was higher than the lower limit of detection);
• •7. Other malignancies in the past 5 years, not including cured skin basal-cell carcinoma and carcinoma in situ of the cervix;
• •8. Pregnant or lactating women.