Actively Recruiting
Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of HRX215 After Major Liver Surgery for Colon Cancer Metastases with Pilot Parts After Minor and Major Liver Resection
Led by HepaRegeniX GmbH · Updated on 2026-05-07
80
Participants Needed
4
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, tolerability, and clinical activity of HRX215 in adults who have had liver surgery due to colorectal cancer metastases. The study includes participants undergoing minor or major liver resections and compares HRX215 to a placebo to understand how the drug is absorbed, distributed, and eliminated by the body. Participants will take HRX215 or placebo capsules twice daily for 28 days. The study has three parts: a pilot with 5 participants after minor liver resection, a pilot with 10 participants starting treatment before major liver resection, and a randomized phase with 64 participants receiving either HRX215 or placebo before major liver resection. Participants will have daily visits during the first week, then biweekly visits, plus follow-ups at 3 and 6 months. During the study, participants will undergo checkups, tests, and monitoring of HRX215 levels in the blood. Researchers will assess adverse events over 6 months and evaluate liver volume changes after surgery. The trial will last at least 6 months for each participant, including safety and efficacy assessments, to understand the effects and behavior of HRX215 after liver surgery.
CONDITIONS
Brief Title
Safety of HRX215 in Patients After Minor and Major Liver Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Liver metastases from colon cancer planned for R0-intended liver surgery
- Stable participants within 1 to 3 days after minor liver resection (for pilot part 1)
- Participants undergoing major liver resection (for pilot parts 2 and 3)
- Low estimated risk for post-hepatectomy liver failure
You will not qualify if you...
- Liver cirrhosis
- Presence of clinical ascites before surgery
- Any other hepatobiliary cancer
- Body mass index (BMI) over 35 kg/m2
- ASA score higher than 4
- Presence of peritoneal carcinomatosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants take HRX215 or a placebo orally twice daily for 28 days, starting shortly before or within 1-3 days after liver resection surgery depending on the type of resection.
Daily visits for the first 7 days, then clinic visits every two weeks for 2 visits
Duration - Up to 6 months after treatment start
Participants have follow-up visits to assess safety and efficacy after treatment ends.
Clinic visits at 3 months and 6 months
Trial Site Locations
Total: 4 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Rabin Medical Center
Petah Tikva, Israel
Not Yet Recruiting
3
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
4
Tel-Aviv Sourasky MC
Tel Aviv, Israel
Not Yet Recruiting
Research Team
W
Wolfgang Albrecht, PhD NC
L
Linda Greenbaum, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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