This is a single-arm, open-label, phase II clinical trial. Patients with unresectable hepatocellular carcinoma (HCC) who are eligible for lenvatinib treatment will receive partial transarterial chemoembolization (TACE) targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, in combination with standard lenvatinib therapy. The partial TACE approach is designed as a liver-function-sparing technique that limits ischemic territory while preserving hepatic reserve.
Age ≥ 20 years at the time of signing informed consent
ECOG performance status 0-1
BCLC stage B or C (without main portal vein thrombosis)
Child-Pugh score 5-7 (Class A or B7) within 28 days of registration
Main portal vein thrombosis
Prior locoregional therapy within 4 weeks
Uncontrolled hypertension
Clinically significant cardiovascular disease within 6 months
Single group
Lenvatinib
DrugOral lenvatinib 12 mg once daily for body weight 60 kg or greater, or 8 mg once daily for body weight less than 60 kg. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Partial transarterial chemoembolization (TACE)
Procedure/SurgeryTransarterial chemoembolization targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, performed within 4 weeks after starting lenvatinib. This liver-function-sparing approach limits the ischemic territory in order to preserve hepatic reserve.
1-year progression-free survival (PFS) by mRECIST
Percentage of participants alive and free of disease progression at 1 year. Progression-free survival is measured from the start date of study treatment to the date of first documented disease progression according to modified RECIST (mRECIST) or death from any cause, whichever occurs first.
1-year overall survival (OS)
Percentage of participants alive at 1 year. Overall survival is measured from the start date of study treatment to the date of death from any cause.
Objective response rate (ORR) by mRECIST
Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by modified RECIST (mRECIST). Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.
Objective response rate (ORR) by RECIST v1.1
Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by RECIST version 1.1. Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.
Disease control rate (DCR) by mRECIST
Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by modified RECIST (mRECIST). Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
Maximum percentage reduction from baseline in the sum of viable target lesion diameters, as assessed by modified RECIST (mRECIST). Reported as percentage change from baseline.
Change from baseline in immune cell subset frequencies assessed by multiparametric flow cytometry
Change from baseline in the frequencies of peripheral blood immune cell subsets measured by multiparametric flow cytometry, including CD4+ and CD8+ T cells, regulatory T cells, natural killer cells, mucosal-associated invariant T cells, and myeloid populations, together with the activation and exhaustion markers PD-1, TIM-3, HLA-DR, and CD38. Reported as percentage of live cells.
Change from baseline in immune cell composition assessed by single-cell RNA sequencing
Change from baseline in immune cell composition measured by single-cell RNA sequencing of peripheral blood mononuclear cells and tissue samples, reported as percentage of sequenced cells assigned to each annotated immune cell cluster.
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