HRX215 for Colorectal Liver Metastases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called HRX215 (experimental treatment) to assess its safety and how the body processes it in individuals who have undergone surgery to remove colon cancer that spread to the liver. The study compares HRX215 to a placebo to identify any health issues participants might experience. It suits those who recently had surgery to remove liver tumors from colon cancer and have normal liver function otherwise. Participants will take the treatment or placebo twice daily for 28 days, with regular checkups and tests to monitor their health. As a Phase 1 trial, participants will be among the first to receive HRX215, aiding researchers in understanding how the treatment works in people.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is examining HRX215 to determine its safety and tolerability in adults with liver cancer that has spread from the colon. Currently, limited information exists on responses to HRX215, as it remains in the early testing phase. At this stage, researchers focus primarily on understanding its safety.
The treatment targets individuals who have undergone liver surgery due to cancer spread. Early studies on similar treatments suggest that drugs like HRX215 might aid liver recovery post-surgery. This indicates HRX215 could potentially support liver healing, though its safety continues to be closely monitored.
Since HRX215 is in an early trial phase, its safety is not yet fully established. Researchers will closely monitor participants for any side effects or issues to ensure their well-being during the study.12345Why do researchers think this study treatment might be promising for colorectal liver metastases?
Researchers are excited about HRX215 for colorectal liver metastases because it offers a potentially novel way to tackle cancer that has spread to the liver. Unlike the standard of care, which typically involves chemotherapy and surgical resection, HRX215 is an oral medication taken twice daily, making it potentially more convenient for patients. Additionally, HRX215 is being evaluated both after major and minor liver resections, providing flexibility in its application based on the extent of liver surgery. This approach could lead to new insights into how we can improve recovery and outcomes for patients undergoing liver resection due to colorectal cancer metastasis.
What evidence suggests that HRX215 might be an effective treatment for colorectal liver metastases?
Research has shown that HRX215 could be a promising treatment for cancer that has spread to the liver. In this trial, participants will receive either HRX215 or a placebo after liver resection surgeries. HRX215 aids in liver self-healing, which is beneficial after surgeries where part of the liver is removed. Studies have found that HRX215 speeds up liver recovery by blocking a specific protein. This may help prevent serious liver problems in patients who have had a large portion of their liver removed. Although still in early stages, these findings suggest that HRX215 could improve recovery after liver surgeries related to cancer.45678
Who Is on the Research Team?
Linda E Greenbaum, M.D.
Principal Investigator
HepaRegeniX GmbH
Patrick Starlinger, M.D., Ph.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 who've had certain liver surgeries due to colon cancer spread. They must have a portion of their liver remaining (28%-50% for the main study, over 69% for the pilot phase) and normal liver function proven by recent tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HRX215 or placebo twice daily for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HRX215
Find a Clinic Near You
Who Is Running the Clinical Trial?
HepaRegeniX GmbH
Lead Sponsor