Tests HRX215 in adults recovering from liver surgery for colorectal cancer spread
Tests HRX215 capsules against placebo in adults after liver surgery for colon cancer spread.
Plain-language title generated from the registry record
Registry title: Safety of HRX215 in Patients After Minor and Major Liver Resection
Key facts
- Where
- Essen and Tübingen, GermanySee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06638502, who can take part
Where in Germany
- Universitätsklinikum EssenEssen, GermanyTaking people
- Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und TransplantationschirurgieTübingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HepaRegeniX GmbH
- Trial code
- NCT06638502
- Record updated
- 14 September 2026
- Original description
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.Read full original descriptionShow less
Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases
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: 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: Any other hepatobiliary cancer; Liver Cirrhosis; Preoperative presence of clinical ascites; BMI >35 kg/m2; ASA Score >4; Peritoneal carcinomatosis; Further exclusion criteria apply.