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.
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.
Parallel
RC148 (Dose 1) plus Capecitabine and Oxaliplatin
DrugRC148 (Dose 1) plus Capecitabine and Oxaliplatin
RC148 (Dose 2) plus Capecitabine and Oxaliplatin
DrugRC148 (Dose 2) plus Capecitabine and Oxaliplatin
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1
Duration of Response (DoR)
Duration of Response (DoR) assessed by the investigator according to RECIST v1.1
Disease Control Rate (DCR)
Disease Control Rate (DCR) assessed by the investigator according to RECIST v1.1
Time to Response (TTR)
Time to Response (TTR) assessed by the investigator according to RECIST v1.1
Overall Survival (OS)
OS
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