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

NCT ID: NCT06519721

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-07-31

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.

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lenvatinib Combined with VIC-1911

Intervention Type: 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 2: Expansion phase

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

Group Type: EXPERIMENTAL

Lenvatinib Combined with VIC-1911

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qiang Xia, MD, PhD

Role: primary

xiaqiang@medmail.com.cn

021-68383651 ext. 86

Other Identifiers

RJ-LY2022-024-B

Identifier Type: -

Identifier Source: org_study_id