NCT07297654

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

First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment: A Phase 2 FINELAND Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

\<Treatment Phase\> All participants will receive lenvatinib treatment after signing informed consent. Lenvatinib will be administered orally once daily at a dose of 8 mg, at the same time each day, with or without food. Treatment must begin within 3 days after screening and will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. \<Follow-up Phase\> After the treatment phase, participants will be followed every 12 weeks (±7 days) after the last dose for survival status and use of subsequent anticancer therapies. Survival follow-up will be conducted for at least 12 months after enrollment of the last participant.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib will be administered orally at a dose of 8 mg once daily at the same time each day, with or without food (regardless of body weight). For participants with a baseline body weight ≥60 kg who tolerate lenvatinib at 8 mg once daily (i.e., experiencing only Grade 1 or lower adverse events) and have maintained this dose for at least 2 weeks, the daily dose of lenvatinib may be increased to 12 mg.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-12-22
• Last updated: 2026-01-07