Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.

History of other active malignancies within the past 3 years, except for locally curable tumors deemed by the investigator to have a low risk of recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)

Has not recovered from adverse events (AEs) due to prior anti-tumor therapy (i.e., not recovered to ≤ Grade 1 or to baseline, with the exception of alopecia, hypothyroidism controllable with hormone replacement therapy, and well-controlled type 1 diabetes on insulin therapy).

Prior treatment with EGFR-targeted antibodies (e.g., cetuximab, panitumumab, etc.), antibody-drug conjugates (ADCs) (e.g., MRG003, SHR-A1307, RC-68, etc.), or signal transduction inhibitors (e.g., gefitinib, osimertinib, etc.).

Currently participating in and receiving investigational drug therapy from another clinical trial, or has received investigational drug therapy or used an investigational device within 4 weeks prior to the first dose of study treatment (Note: this does not include the follow-up period of a study).

Major surgery within 4 weeks prior to the first dose of study treatment, or open biopsy within 1 week prior. (Minor procedures such as mediastinoscopy, placement of a central venous access device, placement of a gastric tube, needle biopsy, and percutaneous nephrostomy are not considered major surgery).

Any chemotherapy, immunotherapy, experimental therapy, or other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter, but at least 14 days) prior to the first dose of study treatment. Treatment with anti-tumor traditional Chinese medicine preparations or any radiotherapy within 2 weeks prior to the first dose of study treatment.

Known central nervous system metastases and/or carcinomatous meningitis. Ascites, pleural effusion, or pericardial effusion requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.

Known active infection requiring systemic therapy administered intravenously within 2 weeks prior to the first dose of study treatment.

Known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Participants with active or chronic hepatitis B (HBsAg positive and HBV DNA ≥2000 IU/mL or ≥10,000 copies/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection. (Participants who are HBsAg positive or HBV-DNA positive at screening are recommended to receive antiviral therapy during the study according to clinical practice).

Clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment, including but not limited to myocardial infarction, severe/unstable angina, primary cardiomyopathy, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), or congestive heart failure (New York Heart Association class \> II); symptomatic coronary artery disease requiring medication; arrhythmia requiring medication; QTcF interval \> 480 ms on electrocardiogram; or uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite adequate medication).

Significant clinically significant bleeding symptoms or a definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, or vasculitis, within 6 months prior to the first dose of study treatment.

Known hypersensitivity or allergic reaction to any component of the study treatment.

History of allogeneic tissue/solid organ transplantation or graft-versus-host disease.

Treatment with any live vaccine within 4 weeks prior to the first dose of study treatment (with the exception of live-attenuated vaccines).

Known psychiatric or substance abuse disorder that would interfere with compliance with study requirements.

Any underlying medical condition that, in the investigator's judgment, would make the administration of the study drug hazardous to the participant or would obscure the interpretation of toxicity or adverse events.

Any other condition for which the investigator deems the participant unsuitable for enrollment.

What this study is about