RightFit
RecruitingPhase 1 / Phase 2

Safety of HRX215 in Patients After Minor and Major Liver Resection

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 28 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will take HRX215 or a placebo twice a day for 28 days."
  • "Clinic visits every two weeks for the next two visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests HRX215 in adults having liver surgery for cancer that spread from the colon or rectum to the liver. Researchers will compare HRX215 with a placebo, a look-alike with no drug, to check its safety, side effects, and activity. They will also study how the body takes in, moves, and removes HRX215.

The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases. The objectives are: 1. to learn about the safety and tolerability of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215. 3. to learn about clinical activity of HRX215 Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cancer that spread from the colon to the liver, with surgery planned to remove all of the liver cancer.
  • Part 1: Be stable 1–3 days after removal of a small part of the liver, with normal liver tissue outside the tumors.
  • Parts 2 and 3: Have surgery to remove a large part of the liver.
  • Have a low estimated risk that the liver will stop working well after surgery.
  • Other rules for joining also apply.

Who can't join

  • Have cirrhosis, or severe scarring of the liver.
  • Have fluid buildup in the belly before surgery.
  • Have another cancer of the liver, gallbladder, or bile ducts.
  • Have a body mass index (BMI), a measure based on height and weight, above 35.
  • Have an ASA score above 4, a rating of health before surgery.
  • Have cancer spread to the lining of the belly.
  • Other rules that may prevent joining also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (4)

MD

MN

NC

OH