Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)

Inclusion criteria

• Must have locally advanced/borderline resectable hepatocellular carcinoma.
• Must have measurable disease.
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
• Patients must have adequate liver remnant and function.
• Antiviral therapy per local standard of care for hepatitis B.
• Woman of child bearing potential must have a negative pregnancy test.
• Must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion criteria

• Fibrolamellar carcinoma or mixed HCC.
• Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months prior to trial registration.
• Concomitant Anticoagulation therapy.
• Any GI or pulmonary risks of bleeding.
• History of HIV Infection.
• Active co-infection with hepatitis B and hepatitis C.
• Active co-infection with hepatitis B and hepatitis D.
• Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.
• History of any autoimmune disease requiring systemic treatment within the past 2 years. Any patient bearing an allograft is not eligible.
• Any additional malignancies with treatment or life-limiting cancers. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial.
• Uncontrolled intercurrent illness.
• Corrected QT interval calculated by the Fridericia formula.
• Uncontrolled high blood pressure.
• Are pregnant or breastfeeding.
• Any gastrointestinal (GI) disorders.
• Any certain study-specified heart conditions 6 months prior to enrollment.
• Major surgery within 2 months before enrollment.
• Have any evidence of moderate or severe ascites.
• Any untreated or incompletely treated varices with bleeding or high-risk bleeding.
• Inability to swallow intact tablets.
• Known or suspected hypersensitivity to study treatment.