Safety of HRX215 in Patients After Minor and Major Liver Resection

Launched by HEPAREGENIX GMBH · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called HRX215 to see if it is safe for adults who have had surgery to remove liver tumors caused by colorectal cancer. The main goals of the study are to find out how well patients tolerate HRX215 and how the body processes the medication. Participants will either receive HRX215 or a placebo (which looks like the medication but contains no active ingredients) for 28 days. They will have daily check-ups for the first week to monitor their health, followed by visits every two weeks for the next month, and additional follow-ups at three and six months after starting treatment.

To be eligible for this trial, participants should be between 18 and 75 years old and have recently undergone liver surgery for colorectal cancer, with certain health criteria met. However, individuals with liver cirrhosis, certain other liver issues, or those whose tumors cannot be surgically removed will not qualify. This study is not yet recruiting participants, but it aims to help researchers understand if HRX215 can be a safe treatment option for patients after liver surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Stable male and female patients between 18 and 75 years within 1-3 days after extended resection of the right or left liver lobe due to metastases of a colon carcinoma, but otherwise normal liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery and liver functional parameters.
• • 2. For the pilot phase less extended resections (remnant liver volume \>69%) are required)
• • 3. Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study)
• • -
• Exclusion Criteria:
• • 1. Liver Cirrhosis
• • 2. Preoperative presence of clinical ascites
• • 3. Any other liver cancer
• • 4. BMI \>35 kg/m2
• • 5. ASA Score\>4
• • 6. CC Score \>0: all patients with pre-operatively or intra-operatively diagnosed peritoneal carcinosis or other pre-op or intra-op findings which would deem the patient to be unresectable, are excluded.
• • 7. Incomplete liver metastasis resection -