Clinical trial · Observational
Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT
Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Large Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: a Multicenter Retrospective Cohort 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)
This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups.
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 Non-resectable | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Len+DEB-TACE | Procedure | — | UNRESOLVED |
| Len+DEB-TACE+HAIC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Len+DEB-TACE+HAIC
- description
- Patients were treated with Len+DEB-TACE+HAIC.
- interventionNames
- Procedure: Len+DEB-TACE+HAIC
- label
- Len+DEB-TACE
- description
- Patients were treated with Len+DEB-TACE.
- interventionNames
- Procedure: Len+DEB-TACE
Primary outcomes (1)
- measure
- Time to progression (TTP)
- timeFrame
- 3.5 years
- description
- defined as the time from treatment initiation to the first occurrence of disease progression.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * a confirmed diagnosis of HCC * the largest intrahepatic lesion \>7 cm * presence of major PVTT on imaging * Eastern Cooperative Oncology Group performance status ≤1 * Child-Pugh class A/B * adequate hematologic and organ function, with leukocyte count 3.0 109/L, neutrophil count 1.5 109/L, platelet count 75 109/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase 5 upper limit of the normal, creatinine clearance rate 1.5 upper limit of the normal, and prothrombin time prolongation \<4 s Exclusion Criteria: * incomplete medical records * central nervous system involvement * previous treatment with transarterial embolization, TACE, HAIC, radiotherapy, or systemic therapy * history of malignancies other than HCC * history of organ transplantation * severe cardiac, pulmonary or renal dysfunction
References
Publications (1)
- DERIVEDCai M, Liang L, Zhang J, Chen N, Huang W, Guo Y, Hong X, Lin L, Liu Y, Dan C, Deng H, Liu X, Zhou J, Chen Y, Chen H, Zhu K. Lenvatinib plus drug-eluting bead transarterial chemoembolization with/without hepatic arterial infusion chemotherapy for hepatocellular carcinoma larger than 7 cm with major portal vein tumor thrombosis: a multicenter retrospective cohort study. Int J Surg. 2024 Dec 1;110(12):7860-7870. doi: 10.1097/JS9.0000000000001819. PMID 38869974