Safety of HRX215 After Liver Surgery for Colorectal Cancer

This study is looking at the safety and tolerability of a drug called HRX215 in adults aged 18 to 75 who have had liver surgery (liver resection) for colorectal cancer that has spread to the liver (colorectal carcinoma liver metastases). Researchers want to see if HRX215 is safe and how your body handles it. You would take HRX215 capsules or a placebo (an inactive substance that looks like the drug) twice a day for 28 days. The study will measure any side effects you experience for up to 6 months and check HRX215 levels in your blood for 28 days. The study aims to enroll 80 participants, but its current status is unclear.

Study design
This is an interventional study comparing HRX215 to a placebo. It plans to enroll 80 participants.
What's involved
You would take HRX215 or placebo twice daily for 28 days. This includes daily visits for the first 7 days, then clinic visits every two weeks for the next two visits, and additional visits at 3 and 6 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events for 6 months after starting treatment.

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NCT06638502

Safety of HRX215 in Patients After Minor and Major Liver Resection

Recruiting
PHASE1Ages 18–75InterventionalTreatment
HepaRegeniX GmbH
~80 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:HRX215 capsulesPlacebo capsules

At a glance

Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events (AEs) observed
Measured over 6 months
+1 more outcome measured
Liver Resection
Colorectal Carcinoma Liver Metastases
12 sites across 7 states
Israel3
Spain3
France2
Maryland1
Minnesota1
Ohio1
Germany1
  • Linda E Greenbaum, MD · STUDY_DIRECTOR · HepaRegeniX GmbH
  • Patrick Starlinger, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Liver Cirrhosis
Preoperative presence of clinical ascites
Any other hepatobiliary cancer
BMI \>35 kg/m2
ASA Score \>4
Peritoneal carcinomatosis
  • Adverse Events (AEs) observed6 months

    Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.

  • HRX215 plasma levels28 days

    Levels of drug (HRX215) at selected time intervals after drug administration