TACE plus lenvatinib versus lenvatinib alone for unresectable liver cancer
Official title: Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma
Run by Bangladesh Medical University · NCT07408804 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Bangladesh Medical University Academic / other |
| Drugs / interventions | lenvatinib |
| Locations | 1 site (Dhaka) |
| Status | Recruiting |
| Started | April 8, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07408804 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Department of Hepatology, Bangladesh Medical University
Dhaka, Bangladesh Recruiting
Study contacts
- Principal investigator: Sourav Kumar Chakraborty
- Study coordinator: Sourav Kumar Chakraborty
- Email: drsouravhepato@gmail.com
- Phone: +8801747473455
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.