Clinical trial · Interventional
Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma
NCT07408804CI-TRIAL-00103254recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 .
References
Publications (2)
- BACKGROUNDYamashita 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 31720835
- BACKGROUNDPeng 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 35921605