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New hope for liver cancer return after transplant: drug trial launches

NCT ID NCT04204850

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called cabozantinib in 20 adults whose liver cancer returned after a liver transplant. The goal is to see if the drug can control the cancer. Participants take the drug until it stops working or side effects become too bothersome.

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 20 people

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

Started

Aug 2020

Expected to finish

Jun 2026

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 years and older

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: * Have histologically or cytologically confirmed hepatocellular carcinoma that has recurred. * Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma (HCC). * Not amenable to curative surgery or local treatment for recurrent disease. * Must have measurable disease. * No prior treatment with cabozantinib. May be systemic therapy naïve or have received up to 1 line of prior therapy for advanced HCC with sorafenib or lenvatinib. * Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 01. * Life expectancy of \>3 months. * Normal organ and marrow function. * Adequate cardiac function. * No evidence of active uncontrolled infection. * Understand and willing to sign written informed consent document. * Recovered from prior toxicities to \< grade 1. * Able to take oral medications. * Agree to use effective contraceptive methods until at least 30 days (for women) and 3 months (for men) after the last administration of study medication. Serum pregnancy test should be negative. Exclusion Criteria: * Had systemic therapy or radiotherapy \<3 weeks. * Receiving any other investigational agents. * With known brain metastases unless stable for \>3 months. * History of allergic reactions attributed to cabozantinib. * Has uncontrolled, significant intercurrent or recent illness: * Cardiovascular disorders * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation * Major surgery within 2 months before randomization * Cavitating pulmonary lesion(s) or endobronchial disease (untreated) * Lesion invading a major blood vessel * Clinically significant bleeding risk \<3 months * Other clinically significant disorders: * Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness * Serious non-healing wound/ulcer/bone fracture * Malabsorption syndrome * Uncompensated/symptomatic hypothyroidism * Requirement for hemodialysis or peritoneal dialysis * Pregnant women. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures * Active hepatitis B or C in liver graft * Patients with a grade \>= 2 elevated liver enzymes who are suspected of cellular rejection will undergo biopsy. Patients diagnosed with cellular rejection in the biopsy sample using the Banff schema are ineligible. * Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma * Moderate or severe ascites * Concomitant use of anticoagulants at therapeutic doses * Has a known history of prior invasive malignancy except if patient has undergone curative-intent therapy with no evidence of disease recurrence for 2 years prior to study entry.

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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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

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