New hope for liver cancer return after transplant: drug trial launches
NCT ID NCT04204850
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Other studies related to the condition(s) this trial covers.
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