Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma

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

DRUG

Lenvatinib

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

Sponsors & Collaborators

• Eisai Inc.

  collaborator INDUSTRY

• Chonnam National University Hospital

  collaborator OTHER

• Seoul National University

  collaborator OTHER

• Gangneung Asan Hospital

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Chosun University Hospital

  collaborator OTHER

• Dong-A University Hospital

  collaborator OTHER

• Bundang CHA Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Yonsei University

  collaborator OTHER

• Hanyang University Seoul Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Saint Vincent's Hospital, Korea

  collaborator OTHER

• Gyeongsang National University Hospital

  collaborator OTHER

• Ewha Womans University

  collaborator OTHER

• Chungbuk National University Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Bucheon St. Mary's Hospital

  collaborator OTHER

• Asan Medical Center

  lead OTHER

Principal Investigators

• Changhoon Yoo, MD, PhD · Asan Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-20

Primary Completion

2026-11-01

Completion

2027-11-01

Countries

• South Korea

Study Locations