Study to Test Safety and Effectiveness of HRX215 Compared to Placebo in Adults After Minor and Major Liver Surgery for Colon Cancer Metastases

What this Trial Is About

Researchers are evaluating HRX215 for safety, tolerability, and clinical activity in adults who have had liver surgery due to colorectal cancer that has spread to the liver. This study includes participants undergoing minor and major liver resections and compares HRX215 to a placebo to understand how the drug behaves in the body and its effects after surgery. Participants will take HRX215 or a matching placebo capsule twice daily for 28 days. For those undergoing major liver resection, treatment begins shortly before surgery. The study includes two pilot groups for minor and major liver resections, followed by a larger randomized group receiving either HRX215 or placebo. Treatment is monitored closely during the first week with daily visits, then biweekly clinic visits, and follow-up visits at 3 and 6 months. During the study, participants will have clinical checkups, blood tests to monitor HRX215 levels, and assessments of liver volume and recovery. Researchers will track adverse events for six months and measure drug levels in the blood over 28 days. The study aims to understand both safety and how the liver responds after surgery, with total participation lasting up to six months.

Safety of HRX215 in Patients After Minor and Major Liver Resection