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

Second Affiliated Hospital of Guangzhou Medical University238 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

238

Conditions

Hepatocellular Carcinoma Non-resectable

Interventions

SIRT-L-PCOMBINATION_PRODUCT

Patients received 1-2 session of SIRT. Lenvatinib and PD-(L)1 inhibitor was initiated within 7 days after the first SIRT and continued until unacceptable toxicity, disease progression, initiation of new therapy, or loss to follow-up.

TACE-L-PCOMBINATION_PRODUCT

Patients received TACE. TACE was repeated for viable tumors demonstrated by follow-up imaging in patients without worsening liver function or contraindications (on-demand TACE). Lenvatinib and PD-(L)1 inhibitor was initiated within 7 days after the first SIRT and continued until unacceptable toxicity, disease progression, initiation of new therapy, or loss to follow-up.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Progression-free survival

The time from the first SIRT or TACE procedure until the date that progressive disease according to mRECIST or death was confirmed.

Time frame: 32 months

Secondary Outcomes

Objective response rate (ORR)

the percentage of patients with complete or partial response according to mRECIST and RECIST 1.1

Time frame: 32 months

Overall survival

the time from the first SIRT or TACE until the date of all-cause mortality

Time frame: 32 months

Disease control rate (DCR)

the percentage of patients with complete, partial response, or stable disease according to mRECIST and RECIST 1.1

Time frame: 32 months

Data from ClinicalTrials.gov

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