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Could a pill help the liver regrow and make more cancer surgeries possible?

NCT ID NCT07612007

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a drug called HRX215 in 80 adults with colorectal cancer that has spread to the liver. Before surgery to remove liver tumors, patients often get a procedure (PVE) that blocks blood flow to the tumor area to encourage the healthy part of the liver to grow. HRX215 aims to speed up that regrowth, potentially allowing more patients to have surgery. The study compares HRX215 to a placebo to see if it safely increases liver size and reduces the risk of liver failure.

What this could mean

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

Active substance
HRX215 (a drug that blocks the MKK4 protein to help liver cells regrow)
What this could lead to
If it works, this could help more patients with colorectal cancer that has spread to the liver become eligible for life-saving surgery by improving liver regrowth after a pre-surgery procedure.
What could go wrong
This is an early Phase 2b trial with only 80 participants, so results may not apply to everyone. The drug may not improve liver regrowth enough or could cause unexpected side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 90 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: * REGISTRATION: Adults 18-90 years * REGISTRATION: Individuals with metachronous colorectal carcinoma liver metastases (CRCLM) after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease * REGISTRATION: Measurable intrahepatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon * REGISTRATION: Available CT suitable for volumetric studies on FLR ≤ 21 days * REGISTRATION: Clinical indication for PVE prior to major hepatectomy as evaluated by at least one senior hepatic surgeon * REGISTRATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon * REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * REGISTRATION: Platelets ≥ 100,000/mm\^3 (≤ 15 days prior to registration) * REGISTRATION: Polynuclear neutrophils ≥ 1000/mm\^3 (≤ 15 days prior to registration) * REGISTRATION: Hemoglobin ≥ 9 g/dL (≤ 15 days prior to registration) (post-transfusion participants can be included) * REGISTRATION: Creatinine ≤ 1.5 x upper limit of normal (ULN) (≤ 15 days prior to registration) * REGISTRATION: Bilirubin ≤ ULN (≤ 15 days prior to registration) * REGISTRATION: Albumin ≥ 3 g/dL (≤ 15 days prior to registration) * REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 15 days prior to registration) * REGISTRATION: International normalized ratio ≤ 1.5 (≤ 15 days prior to registration) * REGISTRATION: Of note, a slight deviation from normal ranges of liver function tests, circulating cell counts, and kidney function can be assumed after systemic neoadjuvant chemotherapy prior to PVE (Field et al., 2008; Takamoto et al., 2010; Lock et al., 2017), which is accounted for in the above list. These parameters at inclusion will then serve as patient baseline * REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. Serum or urine human chorionic gonadotropin test is suitable. Can be done with a home test and results reported by participant to the site * REGISTRATION: Provide written informed consent * REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * RANDOMIZATION: Adults 18-90 years * RANDOMIZATION: Individuals with metachronous CRCLM after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease * RANDOMIZATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon * RANDOMIZATION: Measurable intrahepatic disease as defined by RECIST and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon * RANDOMIZATION: Available CT suitable for volumetric studies on FLR ≤ 21 days * RANDOMIZATION: Scheduled for PVE prior to major hepatectomy Exclusion Criteria: * REGISTRATION: Cirrhosis or clinical ascites * REGISTRATION: Patients with synchronous CRCLM and scheduled staged approach (i.e., resection of metastatic hepatic disease after PVE followed by resection of the colorectal primary in a second operation) * REGISTRATION: Any liver cancer other than CRLM * REGISTRATION: Contraindications to imaging or perioperative management: * Allergy/contraindication to iodine contrast * Anticoagulation with heparin/antivitamin K (AVK) that cannot be interrupted for 48 hours * Antiplatelet therapy (e.g., clopidogrel) that cannot be interrupted for 5 days * REGISTRATION: Inability to discontinue cytochrome P450 (CYP)2D6 inhibitor concomitant medication from start of trial treatment to day 28 * REGISTRATION: Inoperability due to underlying chronic diseases and co-morbidities as assessed by the hepatobiliary surgeon during screening visit * REGISTRATION: Anticipated need to start adjuvant chemotherapy prior to completion of 28 day treatment period * REGISTRATION: Positive test at screening for active hepatitis B virus (HBV)/hepatitis C virus (HCV), defined as history of seropositivity for hepatitis B virus (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy), i.e., positive test for anti-hepatitis B core antigen and negative test for anti-hepatitis B surface antibody. Ongoing, non-cured hepatitis C virus (HCV) infection. Likewise, autoimmune hepatitis will be excluded based on serological \[antinuclear antibodies (ANA), smooth muscle antibodies (SMA), and biochemical parameters AST and ALT\], patients with serological and/or biochemical findings suggestive of probable autoimmune hepatitis will be excluded * REGISTRATION: Legal incapacity (persons in custody or under guardianship) * REGISTRATION: Deprived of liberty subject (by judicial or administrative decision) * REGISTRATION: Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social, or psychological reasons * REGISTRATION: Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown * Pregnant persons * Nursing persons * Persons of childbearing potential who are unwilling to employ adequate contraception. Participants of childbearing potential must use highly effective contraception (hormonal methods, intrauterine device (IUD)/intrauterine system (IUS), bilateral tubal occlusion, or vasectomized partner) during treatment and for a defined post-treatment period of 30 days. True abstinence is acceptable if consistent with lifestyle. Barrier methods alone are insufficient unless combined. Male participants with partners of childbearing potential must use condoms and avoid sperm donation during and after treatment * REGISTRATION: Any of the following prior therapies: * Major surgical procedures ≤ 3 weeks prior to registration * Bevacizumab as part of systemic cancer treatment ≤ 2 weeks prior to registration * REGISTRATION: Failure to recover from any adverse events related to any of the following therapies received prior to registration: * Chemotherapy * Immunotherapy * Targeted therapies * Other investigational agents * Radiation therapy * Major surgical procedures * REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * REGISTRATION: Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy * Psychiatric illness/social situations that would limit compliance with study requirements * REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm in the neoadjuvant setting or during active treatment phase of this study (adjuvant treatment after active treatment phase is completed does not apply) * REGISTRATION: Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy at time of study inclusion or within the past five years with the exception of basal cell carcinoma or carcinoma in situ of the cervix. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria * REGISTRATION: History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    1 site. 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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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Other studies related to the condition(s) this trial covers.