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
- Madrid and Valencia, SpainSee the 3 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver metastases from colon cancer who are planned for liver surgery, to test whether HRX215 is safe and active after the operation.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Liver metastases from colon cancer, with surgery planned to remove all visible tumour (R0-intended hepatectomy). Part 1: stable 1-3 days after minor liver resection, with normal non-tumour liver tissue. Parts 2 and 3: major liver resection. Low estimated risk of liver failure after surgery.
- Earlier treatment
- Part 1: minor liver resection 1-3 days before joining. Parts 2 and 3: major liver resection.
Main reasons for not taking part
- Liver cirrhosis
- Fluid in the belly (clinical ascites) before surgery
- Any other cancer of the liver or bile ducts
- BMI above 35 kg/m2
- ASA score above 4
Read by machine on 12 November 2026.
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 Spain
- Hospital Universitario La PazMadrid, SpainContact: Constantino Fondevila Campo, MD, PhDTaking people
- South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario SanchinarroMadrid, SpainContact: Riccardo Caruso, MD, PhDTaking people
- Consorci Hospital General Universitari de ValènciaValencia, SpainContact: José Mir, MD, PhDTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.