About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
Subjects with brain metastases.
Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.
Trial design
Treatments tested in this trial
- RC148 (Dose 1) plus Capecitabine and Oxaliplatin
- RC148 (Dose 2) plus Capecitabine and Oxaliplatin