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Clinical Trials in Canada / NCT04204850
Recruiting Phase 2

Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

NCT04204850 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2020-08-07
Last updated
2025-12-03

Condition(s) studied

Hepatocellular CarcinomaRecurrent CancerLiver Transplant

Investigational drug(s) / intervention(s)

Cabozantinib →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Princess Margaret Cancer Centre Toronto Ontario Recruiting

On this site

📄 Cabometyx (cabozantinib) drug profile →

More University Health Network, Toronto trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04204850 on ClinicalTrials.gov ↗ ← All trials in Canada