NCT06138769

Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma

Multicenter Phase 2 Trial of Lenvatinib in Patients With Unresectable or Metastatic Hepatocellular Carcinoma After Progression on First-line Atezolizumab Plus Bevacizumab

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Although atezolizumab-bevacizumab has been positioned as the standard first-line therapy in unresectable heptocellular carcinoma, eventually most patients progressed on this regimen. Despite of multiple drugs are approved for the management of unresectable hepatocellular carcinoma, only a few trials have been conducted to investigate their efficacy in the second-line setting after the progression on atezolizumab-bevacizumab. Lenvatinib is approved first-line multikinase inhibitor in unresectable hepatocellular carcinoma, but has not yet been investigated as second-line therapy in prospective study. In this single arm phase 2 study, the efficacy and safety of lenvatinib will be investigated for patients who progressed on first-line atezolizumab-bevacizumab.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib 12 mg (body weight 60 kg or greater) or 8 mg (body weight \< 60 kg) once orally every day

Timeline

• Start date: 2023-07-20
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2023-11-18
• Last updated: 2024-07-03

Locations

1 site across 1 country: South Korea