Phase III Study Comparing AK112 Plus Chemotherapy to Bevacizumab Plus Chemotherapy for First-Line Treatment of Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of AK112 combined with chemotherapy compared to bevacizumab combined with chemotherapy as a first treatment for patients with metastatic colorectal cancer. This Phase III study aims to see how well these treatments work to control cancer progression and improve patient outcomes. The study is sponsored by Akeso and includes adult patients up to 75 years old with confirmed metastatic colorectal adenocarcinoma. Participants are randomly assigned to one of two treatment groups. One group receives AK112 with a chemotherapy regimen called FOLFOXIRI including Irinotecan, Oxaliplatin, Leucovorin, and 5-FU for initial treatment, followed by maintenance therapy with Leucovorin and 5-FU plus AK112. The other group receives bevacizumab with the same chemotherapy combination for initial treatment, followed by maintenance with Leucovorin and 5-FU plus bevacizumab. Treatments are given intravenously every two weeks. Throughout the study, participants will be regularly monitored for cancer progression using imaging and other assessments up to approximately three years. Researchers will measure progression-free survival, overall survival, response rates, duration of response, and disease control rate. The study includes safety monitoring and follow-up visits lasting up to about five years. Participants will have assessments of organ function and other health evaluations to track treatment effects and safety.

AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer