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.
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
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma (HCC)
- What is being tested?
- TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib) and Lenvatinib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
Bangladesh1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Transarterial chemoembolization and lenvatinib | Experimental | 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. Receives: Procedure: TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib); Drug: Lenvatinib |
| Lenvatinib | Active comparator | Participants 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.
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)
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
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
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
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.
- First posted13 Feb 2026
- Study start8 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sourav Kumar Chakraborty, Bangladesh Medical University
- Investigators
- Md. Ayub Al Mamun, FCPS (Medicine), Study chairSourav Kumar Chakraborty, Principal investigator
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 31720835Peng 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07408804
- Acronym / sponsor ID
- 5471
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transarterial chemoembolization and lenvatinib | Experimental | Procedure: TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib), Drug: LenvatinibParticipants 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. |
| Lenvatinib | Active comparator | Drug: LenvatinibParticipants in this arm will receive oral lenvatinib monotherapy at standard weight-based dosing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | Transarterial chemoembolization and lenvatinib |
| LenvatinibLenvatinib 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) | Drug | Lenvatinib, Transarterial chemoembolization and lenvatinib |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 31720835Yamashita 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.
- Background: PubMed 35921605Peng 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Md. Ayub Al Mamun, FCPS (Medicine) study chair
Sourav Kumar Chakraborty principal investigator
1 site in 1 country: see every site and its status.
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.