Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Dec 17, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called cabozantinib to see how well it works in treating patients with liver cancer that has come back after a liver transplant. The type of cancer being looked at is called hepatocellular carcinoma (HCC). The goal is to find out if cabozantinib can help control the cancer in these patients who are no longer able to have surgery or other local treatments for their recurring disease.

To participate in this study, patients must be at least 18 years old and have a confirmed diagnosis of recurrent HCC after a liver transplant. They should not have had cabozantinib before and must be in good overall health. During the trial, all participants will receive cabozantinib and will continue taking it as long as it helps them or until they experience side effects that are too difficult to manage. This trial is currently recruiting participants, and it's important for interested individuals to discuss their eligibility with their healthcare provider.

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Eligibility criteria

• 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.