Evaluating the safety of HRX215 after liver surgery for colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and tolerability of HRX215 in adults who have recently undergone surgical removal of liver metastases due to colorectal carcinoma. Participants will receive either HRX215 or a placebo twice daily for 28 days, with daily check-ups for the first week and follow-up visits at two weeks, three months, and six months post-treatment. The study will also evaluate how the body processes HRX215 and compare clinical outcomes such as ICU days and mortality rates between the treatment and placebo groups.

Why it matters

Who can join: the full rules

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

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Duke Cancer Institute
  Durham, North Carolina, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez
  Lille, France Recruiting
• Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB)
  Villejuif, France Recruiting

Study contacts

• Principal investigator: Patrick Starlinger, MD, PhD — Mayo Clinic
• Study coordinator: Wolfgang Albrecht, PhD NC
• Email: info@heparegenix.com
• Phone: +49 7071 7912809

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.