Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

December 2, 2025 updated by: University Health Network, Toronto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Jennifer Knox, M.D.
          • Phone Number: 416-946-2399
        • Principal Investigator:
          • Jennifer Knox, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabozantinib
Cabozantinib, at a dose of 60 mg orally (by mouth), once a day (at bedtime), continuously.
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.
Other Names:
  • CABOMETYX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: 4 months
Proportion of patients with complete response + partial response + stable disease.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 years
Duration of time from start of treatment to time of progression.
3 years
Overall survival
Time Frame: 3 years
Duration of time from start of treatment to time of death.
3 years
Number of Side Effects Reported
Time Frame: 3 years
Duration of time from start of trial until end
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Ipsen

Investigators

  • Principal Investigator: Jennifer Knox, M.D., Princess Margaret Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaboTx
  • CAPCR 19-6312 (Other Identifier: University Health Network)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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