Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

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.

More Hepatocellular Carcinoma (HCC) trials

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment40 (estimated)
SponsorBangladesh Medical University
Academic / other
Drugs / interventionslenvatinib
Locations1 site (Dhaka)
StatusRecruiting
StartedApril 8, 2025
Main results expectedSeptember 30, 2026
Study endsSeptember 30, 2026
Registry record updatedFebruary 13, 2026
Trial IDNCT07408804 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

  • Department of Hepatology, Bangladesh Medical University
    Dhaka, Bangladesh
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.