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

NCT06519721 | Active Not Recruiting

• 1 other identifier: RJ-LY2022-024-B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-Free Survival (PFS)

  2 years

• Overall Survival (OS)

  2 years

Study Arms (2)

Phase 1: Accelerated titration phase

EXPERIMENTAL

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

Phase 2: Expansion phase

EXPERIMENTAL

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

Drug: Lenvatinib Combined with VIC-1911

Interventions

Lenvatinib Combined with VIC-1911 DRUG

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.

Phase 1: Accelerated titration phase; Phase 2: Expansion phase

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: August 6, 2024
• Primary Completion: December 24, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)