This clinical trial is focused on studying a type of cancer known as advanced biliary tract cancer, which affects the bile ducts and gallbladder. The trial is comparing a new treatment called ivonescimab, also known by its code name AK112 / SMT112, with a standard chemotherapy regimen called FOLFOX. FOLFOX is a combination of three drugs: oxaliplatin, fluorouracil, and calcium folinate. The purpose of the study is to determine if ivonescimab is more effective than FOLFOX in treating this type of cancer.

Participants in the study will receive either ivonescimab or FOLFOX as a second-line treatment, which means it is given after the first treatment has not been successful. Ivonescimab is a special type of medication called a PD-1/VEGF bispecific antibody, which is designed to help the immune system fight cancer and block the growth of new blood vessels that tumors need to grow. The study will monitor how long patients live without their cancer getting worse, which is known as progression-free survival.

The trial will also look at other important outcomes, such as overall survival, which measures how long patients live after starting the treatment, and the disease control rate, which checks how well the cancer is managed with the treatment. Additionally, the study will assess the quality of life of participants using specific questionnaires. The trial is expected to run until 2030, with recruitment starting in 2025. Participants will be closely monitored throughout the study to ensure their safety and to gather information on the effectiveness of the treatments.