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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lenvatinib Combined with VIC-1911

Study type: Interventional

Funder types: Other

Identifiers

NCT06519721

RJ-LY2022-024-B

Details and patient eligibility

About

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.

Full 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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Phase 1: Accelerated titration phase

Experimental group

Description:

Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen.

Treatment:

Drug: Lenvatinib Combined with VIC-1911

Phase 2: Expansion phase

Experimental group

Description:

According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.

Treatment:

Drug: Lenvatinib Combined with VIC-1911