Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC

This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.

This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer. Purpose of the Study: To observe and determine the safety and efficacy of lenvatinib combined with VIC-1911 in the treatment of patients with advanced liver cancer. Sample Size: According to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase. Study Subjects: Patients with advanced HCC

Inclusion Criteria: * Gender unrestricted, age 18-75 years; * HCC conforms to AASLD or EASL clinical diagnostic standards; * HCC Barcelona Clinic Liver Cancer (BCLC) staging is C, with at least one measurable tumor in the liver (longest diameter ≥1cm); * Liver function Child-Pugh Class A or Class B with a score of 7; * ECOG score of 0-1; * Platelet count ≥60×10\^9/L, PT time prolongation ≤6 seconds. Exclusion Criteria: * Irreversible coagulation dysfunction, with obvious bleeding tendency; * Patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication; * Patients with unstable or active ulcers, gastrointestinal bleeding; * Patients with untreated heart disease or poorly controlled hypertension as judged by the researcher; * Severe dysfunction of important organs, such as severe cardiopulmonary dysfunction; * Patients with hepatic encephalopathy or refractory ascites requiring treatment; * Human Immunodeficiency Virus (HIV) infection; * Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (activity defined as viral load \> 20000 IU/mL), or HBV, HCV positive patients who refuse to accept standardized antiviral treatment; * Inability to swallow oral medication. * Gastrointestinal diseases that may affect the absorption or tolerance of the study medication. * History of corneal epithelial cysts or other causes of blurred vision, or medical abnormalities found in ophthalmic screening. * Known allergy to VIC-1911 or its components. * Within 4 weeks before the study, radiotherapy or interventional therapy for the disease under study was performed; * Other concurrent antitumor treatments; * The researcher assesses that the patient cannot or is unwilling to comply with the requirements of the study protocol.