First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorNational Cancer Center, Korea

About this trial

This study aims to evaluate the efficacy and safety of lenvatinib as first-line therapy in patients with Child-Pugh class B HCC who are unsuitable for curative treatment.

Eligibility criteria

Qualifiers

Signed informed consent

Age ≥ 19 years at the time of signing informed consent

Histological or clinical diagnosis of HCC according to the Korean Liver Cancer Association-National Cancer Center guidelines

HCC not amenable to curative treatment (e.g., surgical resection, local therapy, liver transplantation)

Disqualifiers

Fibrolamellar carcinoma or sarcomatoid carcinoma

Prior systemic therapy for HCC

Local therapy for HCC (including radiofrequency ablation, microwave ablation, cryoablation, transarterial chemoembolization, radioembolization, or radiotherapy) within 28 days prior to initiation of study treatment, or unresolved complications from such procedures

History of allogeneic stem cell or solid organ transplantation

Trial design

Treatments tested in this trial

  • Lenvatinib

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

National Cancer Center, Korea

Lead sponsor

Asan Medical Center

Collaborator

Seoul National University Hospital

Collaborator

Seoul National University Bundang Hospital

Collaborator

Samsung Medical Center

Collaborator

Hanyang University Guri Hospital

Collaborator