Liver Resection study: HRX215 capsules
Official title Safety of HRX215 in Patients After Minor and Major Liver Resection
ClinicalTrials.gov ID: NCT06638502
What this study is testing
What is HRX215?
an investigational oral capsule being studied as a potential treatment after liver resection for colorectal cancer metastases
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether HRX215 is safe and how it works in people who had liver removal for colorectal cancer. It also looks at how the body handles the drug.
- Who it's for
- You may be able to join if you are an adult who had liver surgery for colorectal cancer and are willing to take a new medicine.
- What's involved
- You will take HRX215 or a pretend treatment. You will have visits and tests to check safety and how the drug behaves in your body.
- Time commitment
- The study lasts several weeks with multiple visits to monitor safety and drug levels.
- Phase 2: a mid-size study of how well it works
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 apply
You likely can't join if
- Liver Cirrhosis
- Preoperative presence of clinical ascites
- Any other hepatobiliary cancer
- BMI \>35 kg/m2
- ASA Score \>4
- Peritoneal carcinomatosis Further exclusion criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Lille, France
- Villejuif, France
- Essen, Germany
- Tübingen, Germany
- Petah Tikva, Israel
- Ramat Gan, Israel
- Madrid, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States; Rochester, Minnesota, United States; Durham, North Carolina, United States; Cleveland, Ohio, United States; Lille, France; Villejuif, France and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.