This clinical trial is focused on studying metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The trial is testing a combination of two treatments: regorafenib and irinotecan, as well as regorafenib alone. Regorafenib is a medication that comes in the form of a film-coated tablet, while irinotecan is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to compare the overall survival of patients receiving the combination of regorafenib and irinotecan with those receiving regorafenib alone. Participants in the study will be randomly assigned to one of these two treatment groups. The study will last for a maximum of 12 months, during which patients will receive their assigned treatment. The trial aims to understand which treatment option is more effective in extending the life of patients with metastatic colorectal cancer who have a specific genetic makeup known as the A/A genotype of Cyclin D1.

Throughout the study, researchers will monitor various aspects of the patients’ health, including their progression-free survival, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. Other factors being observed include the time it takes for the patient’s condition to deteriorate, the rate at which the disease is controlled, and the overall response to the treatment. The safety of the treatments will also be assessed according to established guidelines, and the quality of life of the participants will be evaluated using a specific questionnaire designed for cancer patients.