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Hepatocellular CarcinomaPhase 2NCT04204850

Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

A Phase 2 study testing Cabozantinib in people with Hepatocellular Carcinoma and Recurrent Cancer, run by University Health Network, Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
7 Aug 2020to 30 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Knox, M.D. contact

416-946-2399

jennifer.knox@uhn.ca

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Jennifer Knox, M.D., 416-946-2399

    Jennifer Knox, M.D.

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

The study has three main parts:

Screening: Participants will have test, procedures, and assessments done for safety and eligibility. Some may be done for research purposes only. Several visits may be needed to complete the screening part of the study.

Study Drug Period: During this part, participants will take the study drug as prescribed by the study doctor. While on the study drug, participants will visit the clinic about once a week for tests, procedures, and assessments for safety, eligibility, and research only purposes.

End of Study Drug Visit and Follow-up: Participants will be asked to make an End of Study Drug visit about 30 days after the last dose of study drugs for safety, eligibility, and research only purposes. After this visit, participants will continue to have follow-up visits about every 8 weeks. If participants are experiencing side effects, they will be followed weekly for about 4 weeks, then monthly until resolution or stabilization.

Being tested
Cabozantinib
Medical subject headings
Carcinoma, Hepatocellular, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabozantinibDrug

    Also called CABOMETYX

    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.

Study groups in NCT04204850
Study groupRoleWhat they receive
CabozantinibExperimentalCabozantinib, at a dose of 60 mg orally (by mouth), once a day (at bedtime), continuously.
Receives: Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate

    Proportion of patients with complete response + partial response + stable disease.

    Measured: 4 months

Secondary outcomes (3)

  1. Progression-free survival

    Duration of time from start of treatment to time of progression.

    Measured: 3 years

  2. Overall survival

    Duration of time from start of treatment to time of death.

    Measured: 3 years

  3. Number of Side Effects Reported

    Duration of time from start of trial until end

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start7 Aug 2020
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04204850
Sponsor's protocol ID
CaboTx
Other IDs
CAPCR 19-6312
Status last verified
Dec 2025
First submitted
17 Dec 2019
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Azhie A, Grant RC, Herman M, Wang L, Knox JJ, Bhat M. Phase II clinical trial of cabozantinib for the treatment of recurrent hepatocellular carcinoma after liver transplantation. Future Oncol. 2022 Jun;18(18):2173-2191. doi: 10.2217/fon-2021-1635. Epub 2022 Mar 15.

    PubMed 35287469

  • D'Alessio A, Cammarota A, Prete MG, Pressiani T, Rimassa L. The evolving treatment paradigm of advanced hepatocellular carcinoma: putting all the pieces back together. Curr Opin Oncol. 2021 Jul 1;33(4):386-394. doi: 10.1097/CCO.0000000000000744.

    PubMed 33867478

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Hepatocellular Carcinoma and Recurrent Cancer, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Knox, M.D. (416-946-2399, jennifer.knox@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204850, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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