A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer
This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)
• Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
• Aged 18-75 years old (including 18 years old and 75 years old).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Expected survival period ≥ 12 weeks.
• At least one measurable lesion according to RECIST v1.1 criteria.
• Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.
• Subjects must be able to provide tumor tissue samples for biomarker detection.
• Adequate bone marrow, liver, kidney, and coagulation function.
• Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.