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Safety of HRX215 in Patients After Minor and Major Liver Resection
Trial Status: active
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06638502.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
The study is designed to evaluate primarily the safety of HRX215, first after minor liver
resection and subsequently in participants after major liver resection. Participants
undergoing major liver resection will start treatment shortly before liver resection
surgery and will receive 28 days of treatment with HRX215 or placebo twice daily with
follow up visits at 3 and 6 months.
Participants will take HRX215 or a placebo twice a day for 28 days. Daily visits for the
first 7 days of treatment for checkups and tests which may either be in the hospital or
outpatient after 3 days. Clinic visits every two weeks for the next two visits.
Additional clinic visits 3 months and 6 months after the start of treatment.
The pharmacokinetics will be compared with the results of the phase I studies in healthy
subjects.
Secondary objectives will include evaluation of liver volume and liver volume increase
