SIRT or TACE Plus Lenvatinib and PD-(L)1 Inhibitor in High Burden HCC

Second Affiliated Hospital of Guangzhou Medical University

Status

Completed

Conditions

Hepatocellular Carcinoma Non-resectable

Treatments

Combination Product: SIRT-L-P

Combination Product: TACE-L-P

Study type

Observational

Funder types

Other

Identifiers

NCT06916546

MIIR-25-retro

Details and patient eligibility

About

This multicenter retrospective study evaluated the efficacy and safety of selective internal radiation therapy (SIRT) combined with lenvatinib and PD-(L)1 inhibitors (SIRT-L-P) versus transarterial chemoembolization (TACE) combined with lenvatinib and PD-(L)1 inhibitors (TACE-L-P) in patients with HCC beyond up-to-seven criteria or with portal vein tumor thrombus (PVTT). Tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were compared between the two groups.

Full description

Consecutive patients with HCC beyond up-to-seven criteria or with PVTT treated with SIRT-L-P or TACE-L-P from June 2022 to October 2024 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Clinical outcomes, including tumor response, PFS, OS, and AEs were compared between the two groups.

Enrollment

238 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically or clinically confirmed diagnosis of HCC at BCLC stage B or C (extrahepatic metastases were allowed)
Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
Child-Pugh class A or B7
unresectable HCC with intrahepatic tumor beyond up-to-seven criteria and/or with PVTT.

Exclusion criteria

receipt of other loco-regional therapies, including hepatic arterial infusion chemotherapy, external radiation therapy, or radioactive seed implantation
Prior systemic therapy
History of other malignancies
incomplete medical records