Safety of HRX215 in Patients After Minor and Major Liver Resection (NCT06638502) | Clinical Trial Compass
RecruitingPhase 1/2
Safety of HRX215 in Patients After Minor and Major Liver Resection
United States, France, Israel80 participantsStarted 2025-05-06
Plain-language summary
The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases.
The objectives are:
1. to learn about the safety and tolerability of HRX215
2. to learn about how the body absorbs, distributes, and gets rid of HRX215.
3. to learn about clinical activity of HRX215
Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with liver metastases originating from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases
* Part 1 only: stable participants within 1-3 days after minor liver resection, normal non-tumor liver parenchyma
* Part 2 and 3 only: Major liver resection.
* Low estimated risk for post-hepatectomy liver failure PHLF
Further inclusion criteria apply
Exclusion Criteria:
* Liver Cirrhosis
* Preoperative presence of clinical ascites
* Any other hepatobiliary cancer
* BMI \>35 kg/m2
* ASA Score \>4
* Peritoneal carcinomatosis
Further exclusion criteria apply
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.