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Unresectable Hepatocellular Carcinoma (HCC)NCT07408804

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

A study testing TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib) and Lenvatinib in people with Unresectable Hepatocellular Carcinoma (HCC), run by Bangladesh Medical University at 1 site in Bangladesh.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this interventional study is to compare treatment response between transarterial chemoembolization (TACE) combined with lenvatinib and lenvatinib monotherapy in patients with unresectable hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib) and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBangladesh
Study dates
8 Apr 2025to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years,
  • 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,
  • At least one measurable lesion based on mRECIST criteria,
  • ECOG performance status 0-2,

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sourav Kumar Chakraborty contact

+8801747473455

drsouravhepato@gmail.com

Md. Ayub Al Mamun, FCPS (Medicine) contact

+8801725876589

ayubmamunal@gmail.com

Bangladesh1 site, 1 recruiting
  • Department of Hepatology, Bangladesh Medical University

    Dhaka, 1000

    Md. Ayub Al Mamun Professor, Department of Hepatology, BMU, FCPS ( Medicine ), +8801725876589, ayubmamunal@gmail.com

    Asma Helen Khan Assistant Professor, Department of Hepatology, BMU, FCPS ( Hepatology), +8801732242310

    Recruiting

Other trials in Bangladesh

About this study

The goal of this interventional study is to compare treatment response between transarterial chemoembolization (TACE) combined with lenvatinib and lenvatinib monotherapy in patients with unresectable hepatocellular carcinoma. The study aims to determine whether the addition of TACE to lenvatinib results in improved tumor response compared with lenvatinib alone in a real-world clinical setting.

Read the detailed description

Hepatocellular carcinoma (HCC) remains a major cause of cancer-related mortality, particularly in low- and middle-income countries where access to advanced interventional oncology services is often limited. Transarterial chemoembolization (TACE) is an established treatment option for patients with unresectable HCC; however, in real-world clinical practice, TACE cannot be offered to all indicated patients due to multiple constraints, including limited interventional radiology facilities, availability of trained personnel, procedure-related costs, and patient-related factors.

In many resource-limited settings, systemic therapy with tyrosine kinase inhibitors such as lenvatinib is frequently used as an alternative or as initial therapy when TACE is not feasible or must be deferred. Lenvatinib has demonstrated efficacy as monotherapy in unresectable HCC and is widely accessible compared to locoregional therapies. As a result, a significant proportion of patients who would otherwise be candidates for TACE are treated with lenvatinib alone in routine clinical practice.

This study is designed to reflect this real-world scenario and aims to compare treatment response between patients receiving a combination of transarterial chemoembolization plus lenvatinib therapy and those receiving lenvatinib monotherapy. By evaluating radiological response using modified RECIST (mRECIST) criteria, the study seeks to evaluate whether the addition of TACE to lenvatinib improves tumor response compared to systemic therapy alone in patients with unresectable hepatocellular carcinoma.

The findings of this study are expected to provide clinically relevant evidence to guide treatment decision-making in settings where access to TACE is limited, and to help identify whether lenvatinib monotherapy offers a reasonable alternative when locoregional therapy cannot be performed. This pragmatic comparison may assist clinicians in optimizing treatment strategies for unresectable HCC within the constraints of available healthcare resources.

Patients will be primarily selected from the inpatient and outpatient departments of Hepatology of Bangladesh Medical University. Based on inclusion and exclusion criteria patients will be included in the study after taking informed written consent. TACE will be done according to institutional protocol. Lenvatinib will be started after 7 days following TACE to this arm. In another arm, Lenvatinib will started to the patients with an ALBI score 2b , patients who have any contraindication to TACE like history of hepatic encephalopathy, inaccessible site lesion etc. , patients who don't want to undergo TACE after being thoroughly counseled all about the procedure. After 1.5 months biochemical tests will be done to compare the ALBI score and AFP in both groups. In TACE plus lenvatinib arm dynamic CT scan or MRI will be done to assess necessity of second time TACE. After 3 months , dynamic CT scan or MRI will done to assess the tumor response on the basis of mRECIST criteria and biochemical tests will be done to compare the ALBI score and AFP in both groups.

Data will be analyzed using appropriate descriptive and inferential statistical methods. Continuous variables will be summarized using measures of central tendency and dispersion, and categorical variables will be summarized as frequencies and percentages. Comparisons between treatment groups will be performed using appropriate statistical tests. A p value <0.05 will be considered statistically significant.

Being tested
TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib), Lenvatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)Procedure or surgery

    Transarterial Chemoembolization will be done in the radiology department by an interventional radiologist. Lenvatinib will be started after 7 days following TACE according to body weight (8mg/day in patients with a body weight <60 kg and 12mg/day in patients with a body weight of 60 kg or more)

  • LenvatinibDrug

    Lenvatinib will be started according to body weight ((8mg/day in patients with a body weight <60 kg and 12mg/day in patients with a body weight of 60 kg or more)

Study groups in NCT07408804
Study groupRoleWhat they receive
Transarterial chemoembolization and lenvatinibExperimentalParticipants in this arm will receive transarterial chemoembolization (TACE) followed by oral lenvatinib therapy at standard weight-based dosing. TACE will be performed according to institutional protocol, and lenvatinib will be initiated after the patient has recovered from the TACE procedure. Multiple sessions of TACE will be considered.
Receives: Procedure: TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib); Drug: Lenvatinib
LenvatinibActive comparatorParticipants in this arm will receive oral lenvatinib monotherapy at standard weight-based dosing.
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the objective response rate between a combination of Transarterial Chemoembolization and Lenvatinib therapy versus Lenvatinib monotherapy in patients with unresectable Hepatocellular carcinoma

    Measured: at baseline and after 3 months of initiation of treatment

Secondary outcomes (4)
  1. To compare tumor size on dynamic CT scan or MRI according to mRECIST criteria between the TACE plus Lenvatinib group and the Lenvatinib group after 3 months of treatment.

    Measured: at baseline and after 3 months of initiation of treatment

  2. To compare new intrahepatic lesions and/ or extrahepatic metastatic lesions ( portal vein, intra-abdominal lymph node, lungs ) with dynamic CT scan or MRI according to mRECIST criteria between the TACE plus Lenvatinib group and the Lenvatinib group

    Measured: at baseline and after 3 month of initiation of treatment

  3. To compare the Albumin-Bilirubin score (ALBI score) of patients between the TACE plus lenvatinib group and the Lenvatinib group

    Albumin-bilirubin score scale range : -2.6 to +0.20 Lower (more negative) scores indicate better liver function, higher scores (more towards positive) worse liver fuction.

    Measured: at Baseline , 1.5 months and at 3 months after initiation of therapy

  4. To compare the alpha-fetoprotein level of patients between the TACE plus lenvatinib group and the Lenvatinib group

    Serum alpha feto-protein (AFP) level is measured in ng/ml. Lower AFP levels indicate better treatment response.

    Measured: at baseline and after 1.5 months and 3 months after initiation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start8 Apr 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
One group of unresectable hepatocellular carcinoma will receive a combination of transarterial chemoembolization and lenvatinib therapy, and one group will receive lenvatinib monotherapy for 3 months.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408804
Sponsor's protocol ID
5471
Status last verified
Feb 2026
First submitted
29 Jan 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yamashita T, Kudo M, Ikeda K, Izumi N, Tateishi R, Ikeda M, Aikata H, Kawaguchi Y, Wada Y, Numata K, Inaba Y, Kuromatsu R, Kobayashi M, Okusaka T, Tamai T, Kitamura C, Saito K, Haruna K, Okita K, Kumada H. REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset. J Gastroenterol. 2020 Jan;55(1):113-122. doi: 10.1007/s00535-019-01642-1. Epub 2019 Nov 12.

    PubMed 31720835
  • Peng Z, Fan W, Zhu B, Wang G, Sun J, Xiao C, Huang F, Tang R, Cheng Y, Huang Z, Liang Y, Fan H, Qiao L, Li F, Zhuang W, Peng B, Wang J, Li J, Kuang M. Lenvatinib Combined With Transarterial Chemoembolization as First-Line Treatment for Advanced Hepatocellular Carcinoma: A Phase III, Randomized Clinical Trial (LAUNCH). J Clin Oncol. 2023 Jan 1;41(1):117-127. doi: 10.1200/JCO.22.00392. Epub 2022 Aug 3.

    PubMed 35921605

Questions about this trial

What is this clinical trial studying?

A study testing TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib) and Lenvatinib in people with Unresectable Hepatocellular Carcinoma (HCC), run by Bangladesh Medical University at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sourav Kumar Chakraborty (+8801747473455, drsouravhepato@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the objective response rate between a combination of Transarterial Chemoembolization and Lenvatinib therapy versus Lenvatinib monotherapy in patients with unresectable Hepatocellular carcinoma (time frame: at baseline and after 3 months of initiation of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408804, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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