Clinical trial · Interventional
Lenvatinib Combined With TACE to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma
A Prospective Cohort Study of the Effect of Lenvatinib Combined With TACE in Preventing the Recurrence in High-risk Patients With Hepatocellular Carcinoma
NCT03838796CI-TRIAL-00060029unknownN/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 purpose of the study is to observe the effect of Lenvatinib Combined With TACE in preventing the recurrence in high-risk patients with hepatocellular carcinoma.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenvatinib | Drug | Lenvatinib | ALIAS |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- lenvatinib
- description
- use lenvatinib after liver resection in HCC patients
- interventionNames
- Drug: lenvatinib
- type
- ACTIVE_COMPARATOR
- label
- lenvatinib and TACE
- description
- use lenvatinib and TACE after liver resection in HCC patients
- interventionNames
- Drug: lenvatinib
- Procedure: TACE
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The characteristics of the treatment history: No lenvatinib treatment history, no sorafenib allergies. * The characteristics of the tumor: The pathological results is hepatocellular carcinoma. Meet any of the following articles: Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number≥3,Tumor size≥8cm,Tumor margin is not clear and no complete capsule. With the embolus in Portal vein, hepatic vein or bile duct. Preoperative rupture or invasion the adjacent organs. * The characteristics of the patients: The patient age was between 18-75. The American Society of Anesthesiologists(ASA)score was I-III. The Child-pugh score was A. Total bilirubin≤3.0 mg/dL, albumin≥28 g/L, AST, ALT, ALP≤5 times the upper limit of normal value. Routine blood test: the neutrophil≥1.5×10\^9/L, Hb≥8.5g/L,PLT≥75×10\^9/L. The INR≤2.3. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points Exclusion Criteria: * R1/2 or palliative rescted tumor * Pregnant or lactating women. * Patients with other malignant tumor. * Patients with mental illness. * Patients participated in other clinical trials in last three months. * Residual lesions showed by Postoperative digital subtraction angiography(DSA). * Postoperative patients treated with other targeted drugs, PD1 antibody and other immunotherapies, FOLFOX systemic chemotherapy, and HuaiErKeLi drug treatment
References
Publications (5)
- RESULTLlovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1. PMID 14667750
- RESULTSun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. doi: 10.1007/s00432-006-0091-y. Epub 2006 Mar 24. PMID 16557381
- RESULTWang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2. PMID 29420221
- RESULTKudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1. PMID 29433850
- DERIVEDChen JH, Lu L, Zhang XY, Xiang BD, Xu X, Li XC, Huang ZY, Wen TF, Luo LP, Huang J, Zhong JH, Liu ZK, Li CX, Long X, Zhu WW, Yang X, Wang CQ, Jia HL, Zhang JB, Zeng YY, Lu CD, Qin LX. Adjuvant lenvatinib in combination with transarterial chemoembolization for hepatocellular carcinoma patients with high risk of postoperative recurrence: A multicenter prospective cohort study. Hepatobiliary Pancreat Dis Int. 2025 Jun;24(3):277-285. doi: 10.1016/j.hbpd.2025.03.001. Epub 2025 Mar 26. PMID 40187927