Clinical trial · Observational
Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation
Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With Hepatitis B Virus-related Hepatocellular Carcinoma Following Liver Transplantation: a Retrospective Case Control Study
- 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)
High-risk patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) suffer from a high ratio of recurrence after liver transplantation (LT). Lenvatinib, as a novel targeted drug, has shown an excellent effect in the treatment of advanced HCC, but there is no study on its effect in preventing HCC recurrence in the patients undergoing transplantation. Therefore, to evaluate the role of adjuvant lenvatinib in preventing recurrence of high-risk LT recipients with HBV-related HCC, the investigators retrospectively analyzed 23 high-risk patients consisting of lenvatinib group (n=14) and control group (n=9) with HBV-related HCC who underwent LT. Disease-free survival (DFS) and HCC recurrence of the two groups were compared. The adverse events (AEs) and drug tolerance of lenvatinib were evaluated.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- lenvatinib
- description
- high-risk patients with HBV-related HCC who took lenvatinib as adjuvant therapy after liver transplantation
- interventionNames
- Drug: Lenvatinib
- label
- control
- description
- high-risk patients with HBV-related HCC who received routine treatment and follow-up after liver transplantation
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
- up to 3 years
- description
- The disease-free survival (DFS) was defined as the period between the day of LT and the day of HCC recurrence confirmed by imaging.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: 1. The recipients who underwent liver transplantation with the pathologic diagnosis of hepatocellular carcinoma. 2. The extrahepatic metastasis was excluded preoperatively. 3. The patients were defined as "high-risk" for recurrence according to the following criteria: (1) beyond Milan criteria confirmed either by radiology before LT or by pathology after LT, (2) tumor with intrahepatic vascular invasion, (3) Alpha-fetoprotein (AFP)≥400ng/L before LT, (4) presence of microvascular invasion (MVI), (5) tumor with histological poor differentiation according to Edmondson-Steiner classification system(21), (6) multiple satellite lesions around the largest tumors detected either by radiology before LT or by histology after LT, (7) tumor penetrating hepatic capsule, (8) recurrent HCC after resection. 4. ECOG score between 0-1 within 1 week before took lenvatinib. 5. The patients have received regular antiviral treatment. 6. Life expectancy more than 3 months. Exclusion Criteria: 1. The patients took lenvatinib before liver transplantation and assessed as SD or PD according to the mRECIST criteria. 2. The patients suffered from other incurable malignancies within 5 years or at the same time. 3. Distant metastasis of tumor was confirmed by imaging before or within 1 month after transplantation. 4. The patients have not received regular antiviral treatment. 5. The patients had a history of mental illness or abuse of psychoactive drugs. 6. The patients deemed unsuitable by attending doctors.
References
Publications (4)
- 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
- RESULTBriggs A, Daniele B, Dick K, Evans TRJ, Galle PR, Hubner RA, Lopez C, Siebert U, Tremblay G. Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma. Br J Cancer. 2020 Jun;122(12):1754-1759. doi: 10.1038/s41416-020-0817-7. Epub 2020 Apr 8. PMID 32265508
- RESULTSiegel AB, El-Khoueiry AB, Finn RS, Guthrie KA, Goyal A, Venook AP, Blanke CD, Verna EC, Dove L, Emond J, Kato T, Samstein B, Busuttil R, Remotti H, Coffey A, Brown RS Jr. Phase I trial of sorafenib following liver transplantation in patients with high-risk hepatocellular carcinoma. Liver Cancer. 2015 Mar;4(2):115-25. doi: 10.1159/000367734. PMID 26020033
- RESULTTeng CL, Hwang WL, Chen YJ, Chang KH, Cheng SB. Sorafenib for hepatocellular carcinoma patients beyond Milan criteria after orthotopic liver transplantation: a case control study. World J Surg Oncol. 2012 Feb 17;10:41. doi: 10.1186/1477-7819-10-41. PMID 22339891