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.
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)
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
Single group
Lenvatinib
DrugLenvatinib 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.
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.
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of treatment initiation to death from any cause.
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.
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.
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.
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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
This trial is not recruiting at the moment. You can still explore other options:
