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.

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.