Recruiting
Phase 2

Cabozantinib

Sponsor:

University Health Network, Toronto

Code:

NCT04204850

Conditions

Hepatocellular Carcinoma

Recurrent Cancer

Liver Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cabozantinib

Study Details

Brief 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). 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.

Conditions

Hepatocellular Carcinoma

Recurrent Cancer

Liver Transplant

Study ID

NCT04204850

Start date

Aug 7, 2020

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cabozantinib

Cabozantinib, at a dose of 60 mg orally (by mouth), once a day (at bedtime), continuously.

Interventions

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.

Primary outcome measure

  • Disease control rate [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Jennifer Knox, M.D.

416-946-2399jennifer.knox@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Jennifer Knox, M.D.

416-946-2399

Principal Investigator:

Jennifer Knox, M.D.

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-03.