A Phase 2 interventional study of Lenvatinib and Partial transarterial chemoembolization (TACE) in Hepatocellular Carcinoma, sponsored by Chang Gung Memorial Hospital. Not yet recruiting. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment
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.
Primary objective:
-1-year progression-free survival (PFS) by mRECIST
Secondary objectives:
Exploratory Endpoints:
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 40 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Diagnosis of HCC confirmed by histology/cytology or typical imaging features, unsuitable for surgical resection or liver transplantation
Exclusion Criteria:
Prior systemic therapy for HCC
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lenvatinib: Oral administration at 12 mg once daily (body weight ≥ 60 kg) or 8 mg once daily (body weight \< 60 kg). Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal. Partial TACE: Performed within 4 weeks after starting lenvatinib.
Drug: Lenvatinib · Procedure: Partial transarterial chemoembolization (TACE)
Oral 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.
Transarterial 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.
Also known as: Partial TACE
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.
Time frame: 1 year after start of study treatment
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.
Time frame: 1 year after start of study treatment
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.
Time frame: Up to 12 months after start of study treatment
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.
Time frame: Up to 12 months after start of study treatment
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.
Time frame: Up to 12 months after start of study treatment
Disease control rate (DCR) by RECIST v1.1
Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by RECIST version 1.1. Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.
Time frame: Up to 12 months after start of study treatment
Duration of response (DOR) by mRECIST
Time from the date of first documented objective response (complete or partial response) to the date of first documented disease progression, as assessed by modified RECIST (mRECIST). Reported in months.
Time frame: Up to 12 months after start of study treatment
Incidence of hepatic decompensation
Percentage of participants with hepatic decompensation within 30 days after treatment. Hepatic decompensation is defined as any of the following: total bilirubin greater than 3 mg/dL, new or worsened ascites, or hepatic encephalopathy.
Time frame: Within 30 days after treatment
Incidence of treatment-emergent adverse events
Number of participants with treatment-emergent adverse events and serious adverse events, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From first dose of study treatment up to 30 days after the last dose
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.
Time frame: Up to 12 months after start of study treatment
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.
Time frame: Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
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.
Time frame: Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lenvatinib
Chang Gung Memorial Hospital →