Recruiting nowPhase 2Randomised
| Registry number | NCT06638502 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, blinded |
| Taking part | 80 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | HepaRegeniX GmbH |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug HRX215 capsules
- Drug Placebo capsules
What it is measuring
Adverse Events (AEs) observed
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
After part of the liver has been removed for colorectal cancer metastases, the researchers are testing whether HRX215 capsules can be given safely and tolerated better than, or differently from, a placebo. They will also examine how the body handles the drug and look for signs of clinical activity, although the treatment’s mechanism is not described here.
The comparison with placebo is intended to show whether any safety findings or signs of activity are linked to HRX215 rather than recovery or other changes after surgery. The main measured outcome is adverse events, so the clearest improvement would be acceptable safety and tolerability; this trial is not primarily measuring longer survival or delaying cancer growth.
Worth knowing: This is a small, early-phase trial focused mainly on safety, and the available description does not establish what clinical benefit HRX215 might provide.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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 HRX215Researchers 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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 12 sites. Listed in: France, Germany, Israel, Spain, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06638502, registered by HepaRegeniX GmbH on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.