Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

This is an interventional treatment trial for Hepatocellular Carcinoma Read More

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.