← Back to all trials
Recruiting
NCT06638502
Safety of HRX215 in Patients After Minor and Major Liver Resection
Conditions: Liver Resection, Colorectal Carcinoma Liver Metastases
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 80
Sponsor: HepaRegeniX GmbH
Location: Johns Hopkins Hospital Baltimore Maryland
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06638502). StuddyBuddy aggregates publicly available trial information.