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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Samsung Medical Center |
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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.
<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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival (OS) is defined as the time from the date of treatment initiation to 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 |
| Time to progression (TTP) |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoonsun Kim | Contact | +82-10-4795-4675 | eda0208@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Bo Hyun Kim Kim, MD | National Cancer Center | Principal Investigator |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| OTHER |
| Hanyang University Guri Hospital | OTHER |
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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. |
| 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. | 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. | 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. | 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. |