Overview
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.
Description
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
Eligibility
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.