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

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

NCT ID: NCT06519721

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Lenvatinib Combined with VIC-1911
Description: 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.
Arm group label: Phase 1: Accelerated titration phase
Arm group label: Phase 2: Expansion phase

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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

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

Address:
City: Shanghai
Zip: 200127
Country: China

Status: Recruiting

Contact:
Last name: Qiang Xia, MD, PhD

Phone: 021-68383651

Phone ext: 86
Email: xiaqiang@medmail.com.cn

Start date: August 1, 2024

Completion date: July 31, 2026

Lead sponsor:
Agency: RenJi Hospital
Agency class: Other

Source: RenJi Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06519721