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New pill aims to speed liver healing after cancer surgery

NCT ID NCT06638502

Disease control Sponsor: HepaRegeniX GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 12 times

Summary

This study tests an experimental drug called HRX215 in people who had part of their liver removed because colon cancer spread there. The drug is meant to help the liver grow back and work better after surgery. About 80 adults will take either HRX215 or a placebo for 28 days, and researchers will check for side effects and measure liver regrowth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRX215 capsules
What this could lead to
If it works, this could point toward a way to help the liver heal faster after surgery, reducing the risk of liver failure.
What could go wrong
This is a very early (Phase 1/2) trial with only 80 people, so it is not yet known if HRX215 is safe or effective. The drug may cause side effects or show no benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma metastasis from malignant tumor of colon

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal carcinoma liver metastases Colorectal liver metastases Liver resection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez

    RECRUITING

    Lille, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Consorci Hospital General Universitari de València

    RECRUITING

    Valencia, Spain

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Spain

  • Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB)

    RECRUITING

    Villejuif, France

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Israel

  • South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro

    RECRUITING

    Madrid, Spain

  • Tel-Aviv Sourasky MC

    ACTIVE_NOT_RECRUITING

    Tel Aviv, Israel

  • Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie

    RECRUITING

    Tübingen, Germany

  • Universitatsklinikum Essen

    RECRUITING

    Essen, Germany

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