TACE plus lenvatinib versus lenvatinib alone for unresectable liver cancer

Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

This trial will test whether adding transarterial chemoembolization (TACE) to lenvatinib helps people with unresectable hepatocellular carcinoma get better tumor responses than taking lenvatinib alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Bangladesh Medical University (other)
• Drugs / interventions: lenvatinib
• Locations: 1 site (Dhaka)
• Trial ID: NCT07408804 on ClinicalTrials.gov

What this trial studies

This interventional comparison enrolls adults aged 18–75 with untreated, measurable unresectable HCC across BCLC stages A–C and ECOG 0–2. Participants receive either transarterial chemoembolization plus oral lenvatinib or lenvatinib monotherapy in a real-world, single-center setting. Tumor response will be measured radiologically using modified RECIST (mRECIST) criteria to compare outcomes between the two groups. The design reflects resource-limited clinical practice where TACE availability can be constrained and aims to see if adding locoregional therapy improves response over systemic therapy alone.

Who should consider this trial

Good fit: Adults 18–75 with untreated, measurable unresectable hepatocellular carcinoma (BCLC A–C) and ECOG performance status 0–2 who can receive TACE and lenvatinib.

Not a fit: Patients with diffuse bilobar disease involving ≥50% of the liver, main trunk portal vein thrombosis, Child‑Pugh C or ALBI grade 3, recent major cardiac or thromboembolic events, or known lenvatinib allergy are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If adding TACE improves tumor response, patients could achieve longer disease control and potentially improved survival compared with lenvatinib alone.

How similar studies have performed: Observational series and studies combining locoregional therapy with tyrosine kinase inhibitors have suggested improved tumor responses, but randomized or definitive evidence specifically pairing TACE with lenvatinib remains limited.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years,
2. Hepatocellular carcinoma, confirmed by dynamic CT scan / MRI or histopathology, consistent with early (stage A), Intermediate (Stage B), subgroup B, and Advanced (stage C) according to BCLC criteria 2022, without a history of any previous treatment,
3. At least one measurable lesion based on mRECIST criteria,
4. ECOG performance status 0-2,

Exclusion Criteria:

1. Diffuse bi-lobar or multi nodular HCC (more than 10 nodules) with more than equal 50% liver involvement,
2. Hepatocellular carcinoma with main trunk portal vein thrombosis,
3. Child Turcotte Pugh Score 10 ( C) or more,
4. ALBI grade 3,
5. Hepatocellular carcinoma with uncontrolled hypertension, recent myocardial infarction, or other thromboembolic event,
6. Known allergy or intolerance to lenvatinib .

Where this trial is running

Dhaka

• Department of Hepatology, Bangladesh Medical University — Dhaka, Bangladesh (RECRUITING)

Study contacts

• Principal investigator: Sourav Kumar Chakraborty
• Study coordinator: Sourav Kumar Chakraborty

Conditions: Unresectable Hepatocellular Carcinoma