NCT07408804

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Apr 2025Sep 2026

Study Start

First participant enrolled

April 8, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

January 29, 2026

Last Update Submit

February 6, 2026

Conditions

Unresectable Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (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

    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.

    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

    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

    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

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

Study Arms (2)

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.

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.

Drug: Lenvatinib

Interventions

TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)PROCEDURE

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)

Transarterial chemoembolization and lenvatinib
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)

LenvatinibTransarterial chemoembolization and lenvatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatology, Bangladesh Medical University

Dhaka, 1000, Bangladesh

RECRUITING

Related Publications (2)

  • 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: 31720835BACKGROUND

  • 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.

    PMID: 35921605BACKGROUND

Related Links

MeSH Terms

Interventions

lenvatinib

Study Officials

  • Md. Ayub Al Mamun, FCPS (Medicine)

    STUDY CHAIR

  • Sourav Kumar Chakraborty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sourav Kumar Chakraborty

CONTACT

+8801747473455drsouravhepato@gmail.com

Md. Ayub Al Mamun, FCPS (Medicine)

CONTACT

+8801725876589ayubmamunal@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Phase B- MD ( Hepatology), Department of Hepatology, Bangladesh Medical University

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 13, 2026

Study Start

April 8, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)