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

February 6, 2026 updated by: Sourav Kumar Chakraborty, Bangladesh Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Recruiting
        • Department of Hepatology, Bangladesh Medical University
        • Contact:
          • Md. Ayub Al Mamun Professor, Department of Hepatology, BMU, FCPS ( Medicine )
          • Phone Number: +8801725876589
          • Email: ayubmamunal@gmail.com
        • Contact:
          • Asma Helen Khan Assistant Professor, Department of Hepatology, BMU, FCPS ( Hepatology)
          • Phone Number: +8801732242310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transarterial chemoembolization and lenvatinib
Participants 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.
Procedure: TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)
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)
Drug: Lenvatinib
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)
Active Comparator: Lenvatinib
Participants in this arm will receive oral lenvatinib monotherapy at standard weight-based dosing.
Drug: Lenvatinib
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at baseline and after 3 months of initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: at baseline and after 3 months of initiation of treatment
at baseline and after 3 months of initiation of treatment
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
Time Frame: at baseline and after 3 month of initiation of treatment
at baseline and after 3 month of initiation of treatment
To compare the Albumin-Bilirubin score (ALBI score) of patients between the TACE plus lenvatinib group and the Lenvatinib group
Time Frame: at Baseline , 1.5 months and at 3 months after initiation of therapy
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.
at Baseline , 1.5 months and at 3 months after initiation of therapy
To compare the alpha-fetoprotein level of patients between the TACE plus lenvatinib group and the Lenvatinib group
Time Frame: at baseline and after 1.5 months and 3 months after initiation of treatment
Serum alpha feto-protein (AFP) level is measured in ng/ml. Lower AFP levels indicate better treatment response.
at baseline and after 1.5 months and 3 months after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangladesh Medical University

Investigators

  • Study Chair: Md. Ayub Al Mamun, FCPS (Medicine)
  • Principal Investigator: Sourav Kumar Chakraborty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5471

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unresectable Hepatocellular Carcinoma (HCC)

Clinical Trials on TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe