Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:57 PM
Study NCT ID:
NCT07408804
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'at baseline and after 3 months of initiation of treatment'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'at baseline and after 3 months of initiation of treatment'}, {'measure': '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', 'timeFrame': 'at baseline and after 3 month of initiation of treatment'}, {'measure': 'To compare the Albumin-Bilirubin score (ALBI score) of patients between the TACE plus lenvatinib group and the Lenvatinib group', 'timeFrame': 'at Baseline , 1.5 months and at 3 months after initiation of therapy', 'description': '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.'}, {'measure': 'To compare the alpha-fetoprotein level of patients between the TACE plus lenvatinib group and the Lenvatinib group', 'timeFrame': 'at baseline and after 1.5 months and 3 months after initiation of treatment', 'description': 'Serum alpha feto-protein (AFP) level is measured in ng/ml. Lower AFP levels indicate better treatment response.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unresectable Hepatocellular Carcinoma (HCC)']}, 'referencesModule': {'references': [{'pmid': '31720835', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35921605', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31720835/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35921605/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nThis 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.\n\nThe 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.\n\nPatients 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75 years,\n2. 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,\n3. At least one measurable lesion based on mRECIST criteria,\n4. ECOG performance status 0-2,\n\nExclusion Criteria:\n\n1. Diffuse bi-lobar or multi nodular HCC (more than 10 nodules) with more than equal 50% liver involvement,\n2. Hepatocellular carcinoma with main trunk portal vein thrombosis,\n3. Child Turcotte Pugh Score 10 ( C) or more,\n4. ALBI grade 3,\n5. Hepatocellular carcinoma with uncontrolled hypertension, recent myocardial infarction, or other thromboembolic event,\n6. Known allergy or intolerance to lenvatinib .'}, 'identificationModule': {'nctId': 'NCT07408804', 'briefTitle': 'Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Bangladesh Medical University'}, 'officialTitle': 'Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '5471'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transarterial chemoembolization and lenvatinib', 'description': '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.', 'interventionNames': ['Procedure: TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)', 'Drug: Lenvatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lenvatinib', 'description': 'Participants in this arm will receive oral lenvatinib monotherapy at standard weight-based dosing.', 'interventionNames': ['Drug: Lenvatinib']}], 'interventions': [{'name': 'TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)', 'type': 'PROCEDURE', 'description': '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)', 'armGroupLabels': ['Transarterial chemoembolization and lenvatinib']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['Lenvatinib', 'Transarterial chemoembolization and lenvatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'status': 'RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'Md. Ayub Al Mamun Professor, Department of Hepatology, BMU, FCPS ( Medicine )', 'role': 'CONTACT', 'email': 'ayubmamunal@gmail.com', 'phone': '+8801725876589'}, {'name': 'Asma Helen Khan Assistant Professor, Department of Hepatology, BMU, FCPS ( Hepatology)', 'role': 'CONTACT', 'phone': '+8801732242310'}], 'facility': 'Department of Hepatology, Bangladesh Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Sourav Kumar Chakraborty', 'role': 'CONTACT', 'email': 'drsouravhepato@gmail.com', 'phone': '+8801747473455'}, {'name': 'Md. Ayub Al Mamun, FCPS (Medicine)', 'role': 'CONTACT', 'email': 'ayubmamunal@gmail.com', 'phone': '+8801725876589'}], 'overallOfficials': [{'name': 'Md. Ayub Al Mamun, FCPS (Medicine)', 'role': 'STUDY_CHAIR'}, {'name': 'Sourav Kumar Chakraborty', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangladesh Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident, Phase B- MD ( Hepatology), Department of Hepatology, Bangladesh Medical University', 'investigatorFullName': 'Sourav Kumar Chakraborty', 'investigatorAffiliation': 'Bangladesh Medical University'}}}}