Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT

Second Affiliated Hospital of Guangzhou Medical University

Status

Completed

Conditions

Hepatocellular Carcinoma Non-resectable

Treatments

Procedure: Len+DEB-TACE+HAIC

Procedure: Len+DEB-TACE

Study type

Observational

Funder types

Other

Identifiers

NCT06265883

MIIR-16-Retro

Details and patient eligibility

About

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.

Full description

Consecutive patients with large HCC and PVTT treated with lenvatinib plus drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (Len+DEB-TACE+HAIC) or lenvatinib plus DEB-TACE (Len+DEB-TACE) from July 2019 to June 2021 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Clinical outcomes, including tumor response, TTP, OS, and TRAEs were compared between the two groups.

Enrollment

205 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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