Safety of HRX215 in Patients After Minor and Major Liver Resection

Description

The goal of this clinical trial is to learn if HRX215 is safe and tolerable in adults who have undergone surgical removal of metastatic tumor(s) due to colorectal carcinoma in the liver. The main question it aims to answer are: 1. to learn about the safety of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215 . Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to see what medical problems participants have when taking HRX215. Participants will: Take HRX215 or a placebo twice a day for 28 days Daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days. Clinic visits every two weeks for the next two visits. The visit at two weeks may be a home visit or clinic visit. Additional clinic visits 3 months and 6 months after the start of treatment

Conditions

Colorectal Liver Metastases, Liver Resection

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to learn if HRX215 is safe and tolerable in adults who have undergone surgical removal of metastatic tumor(s) due to colorectal carcinoma in the liver. The main question it aims to answer are: 1. to learn about the safety of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215 . Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to see what medical problems participants have when taking HRX215. Participants will: Take HRX215 or a placebo twice a day for 28 days Daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days. Clinic visits every two weeks for the next two visits. The visit at two weeks may be a home visit or clinic visit. Additional clinic visits 3 months and 6 months after the start of treatment

Double Blind, Randomized, Placebo Controlled, Study to Evaluate the Safety of HRX215 in Patients Post Major Hepatectomy, Preceded by an Open Pilot Phase in Patients Post Minor Hepatectomy Due to Metastases of a Colon Carcinoma

Safety of HRX215 in Patients After Minor and Major Liver Resection

Condition
Colorectal Liver Metastases
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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 -

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

HepaRegeniX GmbH,

Linda E Greenbaum, M.D., STUDY_DIRECTOR, HepaRegeniX GmbH

Patrick Starlinger, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-07-01