Evaluating the safety of HRX215 after liver surgery for colorectal cancer
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
This study is testing if a new medication called HRX215 is safe for adults who have just had surgery for liver cancer from colorectal cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | HepaRegeniX GmbH Industry-sponsored |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Trial ID | NCT06638502 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are stable adults aged 18 to 75 who have undergone liver resection for colorectal cancer metastases and have normal liver function.
Not a fit: Patients with liver cirrhosis, other liver cancers, or significant preoperative complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to improve recovery and outcomes for patients after liver resection.
How similar studies have performed: While this approach is novel in the context of HRX215, similar studies evaluating post-surgical treatments have shown promise in improving recovery outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota and 3 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Not_yet_recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Tel-Aviv Sourasky MC — Tel Aviv, Israel (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.