NCT06519721

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-31
• Completion: 2026-07-31
• First posted: 2024-07-25
• Last updated: 2024-08-09

Locations

1 site across 1 country: China