Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

A Phase II Trial of Cabozantinib in the Treatment of Recurrent Hepatocellular Carcinoma Post Liver Transplant

Cabozantinib to Treat Recurrent Liver Cancer Post Transplant (NCT04204850) is a Phase 2 interventional studying Hepatocellular Carcinoma and Recurrent Cancer, sponsored by University Health Network, Toronto. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients. Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors. All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatocellular Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Have diagnosed by tissue sample (biopsy-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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 weakened immune system virus (HIV) or known acquired weakened immune system syndrome (AIDS)-related illness ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Cabozantinib

Cabozantinib is a multi-tyrosine kinase inhibitor with activity against VEGFR 1,2,3, MET and AXL, as well as RET, KIT, ant FLT-3.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04204850), the sponsor (University Health Network, Toronto), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04204850 clinical trial studying?

This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients. Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors. All participants will receive cabozantinib u… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04204850?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04204850?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04204850. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04204850. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.