Phase 12 Study of RC148 Plus Chemotherapy Compared to Bevacizumab Plus Chemotherapy for First Treatment of Unresectable or Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of RC148 combined with chemotherapy as a first treatment option for people with unresectable or metastatic colorectal cancer. This Phase 12 trial aims to compare RC148 plus chemotherapy against bevacizumab plus chemotherapy to understand which approach better controls the disease and improves patient outcomes. The study focuses on patients who have not received prior systemic anti-tumor treatment for metastatic disease and have measurable tumors. Participants will receive one of two doses of RC148 combined with a chemotherapy regimen called CAPEOX, which includes capecitabine and oxaliplatin. The trial is randomized, meaning participants are assigned by chance to one of the treatment groups. The study includes an initial Phase 2 period to evaluate preliminary effects, followed by a Phase 3 period comparing the treatments more extensively. Treatment is given as the first-line therapy for this advanced colorectal cancer. During the study, participants will be monitored for tumor response using standard criteria over 24 months, with additional follow-up to assess overall survival and safety for up to 36 months. Researchers will collect tumor tissue samples for biomarker testing and regularly assess health status, side effects, and disease control. Patients will have scheduled visits for evaluations and laboratory tests throughout the trial to measure treatment impact and safety.

A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer