Study of AK104 with Chemotherapy and Cetuximab or Bevacizumab as Second-Line Treatment for Advanced MSS Metastatic Colorectal Cancer in Adults Aged 18-75

What this Trial Is About

Researchers are evaluating the objective response rate of AK104 combined with chemotherapy and targeted drugs cetuximab or bevacizumab in the second-line treatment of microsatellite stable MSS advanced metastatic colorectal cancer. This single-arm, open-label study focuses on patients with metastatic colorectal adenocarcinoma who have previously received first-line therapy based on oxaliplatin. The study is conducted at a single center and aims to assess both the efficacy and safety of this combination treatment. Participants will receive a combination of AK104 with chemotherapy FOLFIRI and either cetuximab or bevacizumab as their second-line treatment. The treatment regimen is designed to target the cancer more effectively based on the tumors RAS gene status. The study involves only one treatment arm where all participants receive this combination therapy. During the study, participants will be monitored through imaging and clinical evaluations to measure tumor response according to RECIST v1.1 criteria. Researchers will collect tumor tissue samples for analysis and assess organ function through blood tests to ensure participants meet safety requirements. The primary outcome is the objective response rate, which measures the proportion of patients experiencing a significant reduction in tumor size. The study includes follow-up for safety and efficacy until the end date, with a total participation age range from 18 to 75 years old.

Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab