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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Lenvatinib Combined with VIC-1911

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1: Accelerated titration phase; 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.	Drug: Lenvatinib Combined with VIC-1911; Oral administration: Lenvatinib: Take the clinically normal dose: ≤60Kg body weight, 8mg/day; >60Kg body weight, 12mg/day; VIC-1911: Phase 1: Accelerated titration phase 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. Phase 2: Expansion phase According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.
Experimental: Phase 2: Expansion phase; According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.	Drug: Lenvatinib Combined with VIC-1911; Oral administration: Lenvatinib: Take the clinically normal dose: ≤60Kg body weight, 8mg/day; >60Kg body weight, 12mg/day; VIC-1911: Phase 1: Accelerated titration phase 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. Phase 2: Expansion phase According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective Response Rate (ORR) is defined as the proportion of patients experiencing a complete or partial response to a treatment	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Progression-Free Survival (PFS) is defined as the length of time during a study that a patient with a known cancer diagnosis does not experience disease worsening or death due to the disease.	2 years
Overall Survival (OS)	Overall Survival (OS) is defined as the percentage of patients in a study or a group of patients who are alive for a certain period of time after the start of treatment.	2 years

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Actual): December 24, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 21, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: RJ-LY2022-024-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No