Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma

Exclusion Criteria

• •1. Imaging findings for HCC of clear invasion into the bile duct or portal vein invasion with Vp4.
• •2. Positive pregnancy test in female patients with childbearing potential within 72 hours prior to enrollment.
• •3. Prior anticancer treatment or any investigational agent.
• •4. Subjects having ≥2+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥1 g/24-hour will be ineligible.
• •5. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
• •6. New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months.
• •7. Prolongation of corrected QT (QTc , Fridericia formula) interval to \>480 ms.
• •8. Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
• •9. Bleeding or thrombotic disorders or use of factor X inhibitors or anticoagulants requiring therapeutic international normalized ratio (INR) monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin is permitted. Antiplatelet agents are prohibited throughout the study.
• •10. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
• •11. Subject is known to be positive for Human Immunodeficiency Virus (HIV).
• •12. Serious nonhealing wound, ulcer, or bone fracture.
• •13. History of solid organ or hematologic transplant.
• •14. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
• •15. Active, known or suspected autoimmune disease that has required systemic treatment in the past 2 years or a documented history of clinically severe autoimmune disease, or any other syndrome that requires systemic steroids or immunosuppressive agents, patients with hypothyroidism stable on hormone replacement, or type 1 diabetes on insulin replacement will not be excluded from the study.
• •16. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis or has a history of interstitial lung disease.
• •17. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.