Advanced Hepatocellular CarcinomaPhase 2FINELANDNCT07297654
First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment
A Phase 2 study testing Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by National Cancer Center, Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
- Prothrombin time (INR ≤ 1.8 × ULN)
- Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault equation)
- Documented virological status for hepatitis B virus (HBV) and hepatitis C virus (HCV) by screening tests.
- Participants with HBV or HCV infection must receive antiviral therapy in accordance with institutional guidelines.
- Women of childbearing potential must agree to remain abstinent or use effective contraception (failure rate < 1% per year) from signing informed consent through at least 6 months after the last study drug administration.
- Men must agree to remain abstinent or use effective contraception (failure rate < 1% per year) during the same period and refrain from sperm donation.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment: A Phase 2 FINELAND 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.
Read the 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
- Being tested
- Lenvatinib
- Keywords
- Lenvatinib, child Pugh B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Overall survival (OS) is defined as the time from the date of treatment initiation to death from any cause.
Measured: 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)
Time to progression (TTP) 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.
Measured: 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)
Objective response rate (ORR) is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1.
Measured: 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)
Disease control rate (DCR) is defined as the proportion of participants whose best overall response is complete CR, PR, or stable disease (SD), as assessed by the investigator according to RECIST v1.1.
Measured: 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
The incidence of AEs is defined as the number of all AEs occurring in participants from the first dose of the investigational product until the last follow-up visit, as well as the proportion of participants who experience them. The severity of AEs will be graded on a scale of Grade 1-5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study startFeb 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Asan Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital, Samsung Medical Center, Hanyang University Guri Hospital
- Responsible party
- Principal investigator, Bo Hyun Kim, National Cancer Center, Korea
- Investigators
- Bo Hyun Kim Kim, MD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297654
- Sponsor's protocol ID
- NCC2025-0327
- Acronym
- FINELAND
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment: A Phase 2 FINELAND Trial
- ClinicalTrials.gov ID
- NCT07297654
- Acronym / sponsor ID
- FINELAND / NCC2025-0327
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Lenvatinib, child Pugh B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Asan Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital, Samsung Medical Center, Hanyang University Guri Hospital
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib | Experimental | Drug: LenvatinibLenvatinib 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Active brain metastases or leptomeningeal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibLenvatinib 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. | Drug | Lenvatinib |
Primary outcome
Progression-free survival (PFS)
Time frame: 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
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.
5 secondary outcomes
Overall survival (OS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Hyun Kim Kim, MD principal investigator
National Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by National Cancer Center, Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoonsun Kim (+82-10-4795-4675, eda0208@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.