Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

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.