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

NCT07297654 | Not Yet Recruiting Phase 2

• 1 other identifier: NCC2025-0327
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Lenvatinib; child Pugh B

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) is defined as the time from the date of treatment initiation to the date of first documented progressive disease (PD) according to RECIST v1.1, as assessed by the investigator, or death from any cause.

  Twelve months after the last subject is enrolled or the time at which the 41 events required to verify the assumptions used in the sample size calculation have occurred

Secondary Outcomes (5)

• Overall survival (OS)

  Twelve months after the last subject is enrolled or the time at which the 41 events required to verify the assumptions used in the sample size calculation have occurred

• Time to progression (TTP)

  Twelve months after the last subject is enrolled or the time at which the 41 events required to verify the assumptions used in the sample size calculation have occurred.

• Objective response rate (ORR)

  Twelve months after the last subject is enrolled or the time at which the 41 events required to verify the assumptions used in the sample size calculation have occurred.

• Disease control rate (DCR)

  Twelve months after the last subject is enrolled or the time at which the 41 events required to verify the assumptions used in the sample size calculation have occurred.

• The incidence of AEs

  Twelve months after the last subject is enrolled or the time at which the 41 events required to verify the assumptions used in the sample size calculation have occurred.

Study Arms (1)

Lenvatinib

EXPERIMENTAL

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.

Drug: Lenvatinib

Interventions

Lenvatinib DRUG

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.

Lenvatinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• At least one measurable target lesion according to RECIST v1.1
• \- Participants who previously received local treatment (e.g., radiofrequency ablation, microwave ablation, transarterial chemoembolization, transarterial radioembolization, transarterial embolization, or radiotherapy) are eligible if (a) target lesions have not been treated by prior local therapy, or (b) lesions within the field of local therapy have subsequently progressed according to RECIST v1.1.
• Child-Pugh class B7-B8
• ECOG performance status (PS) 0-2
• Adequate hematologic and end-organ function defined by the following laboratory tests obtained within 14 days prior to screening:
• Hemoglobin ≥ 8.0g/dL
• Absolute neutrophil count (ANC) ≥ 1,000/mm3
• Platelet count ≥ 50,000/μL
• Total bilirubin \< 3.5 mg/dL
• Serum albumin ≥ 2.5 g/dL
• ALT and AST ≤ 7 x upper limit of normal (ULN)

You may not qualify if:

• 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
• \- Palliative radiotherapy to bone lesions is permitted with a 7-day washout
• History of allogeneic stem cell or solid organ transplantation
• Active brain metastases or leptomeningeal disease
• History of another malignancy within 2 years prior to screening, except for cancers with negligible risk of metastasis or death (e.g., \>90% 5-year survival)
• Serious uncontrolled medical comorbidities within 3 months prior to study treatment, including severe cardiovascular disease (NYHA class ≥ II heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina, or any condition judged by the investigator to increase participant risk
• Pregnant or breastfeeding women, or men and women of reproductive potential unwilling to use effective contraception from screening through 6 months after the last study drug administration
• Any condition judged by the investigator to interfere with compliance with study procedures, restrictions, or requirements

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Asan Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator
• Hanyang University Guri Hospital: collaborator

MeSH Terms

Interventions

lenvatinib

Study Officials

• Bo Hyun Kim Kim, MD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoonsun Kim

CONTACT

+82-10-4795-4675; eda0208@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01