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Sponsor: HepaRegeniX GmbH
Conditions: Liver Resection, Colorectal Carcinoma Liver Metastases
Interventions: HRX215 capsules, Placebo capsules
Countries: United States, France, Germany, Israel, Spain
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.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Lille, France
- Villejuif, France
- Tübingen, Germany
- Petah Tikva, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Madrid, Spain
- Madrid, Spain
- Valencia, Spain