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Trial Title:
Safety of HRX215 in Patients After Minor and Major Liver Resection
NCT ID:
NCT06638502
Condition:
Colorectal Liver Metastases
Liver Resection
Conditions: Official terms:
Neoplasm Metastasis
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
HRX215 capsules
Description:
HRX215 capsules 250 mg orally twice daily
Arm group label:
Active treatment arm major hepatic resection
Arm group label:
Active treatment minor hepatic resection
Intervention type:
Drug
Intervention name:
Placebo capsules
Description:
placebo capsules matching appearance of HRX215
Arm group label:
placebo arm major hepatic resection
Summary:
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
Detailed description:
The study is designed to evaluate primarily the safety of HRX215, first after minor liver
resection and, when safety is established, in those patients after major liver resection.
Participants will start treatment within 1-3 days after liver resection and will receive
28 day treatment with HRX215 twice daily or placebo with follow up visits 3 and 6 months
after completion of treatment.
The pharmacokinetics will be compared with the results of the phase I studies, whereas
efficacy will be evaluated only descriptively. Secondary objectives will include
evaluation of differences in liver volume recovery postoperatively and clinical outcomes
including days in the ICU and 90 day mortality in participants who receive treatment with
HRX215 vs. placebo.
Criteria for 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 -
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
October 1, 2025
Lead sponsor:
Agency:
HepaRegeniX GmbH
Agency class:
Industry
Source:
HepaRegeniX GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06638502
