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

Yttrium-90 Selective Internal Radiation Therapy (SIRT) Combined With Lenvatinib and PD-(L)1 Inhibitors Versus Transarterial Chemoembolization (TACE) Combined With Lenvatinib and PD-(L)1 Inhibitors for Intermediate-Advanced Hepatocellular Carcinoma: A Multicenter Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma Non-resectable
• Intervention / Treatment: Combination product: SIRT-L-P; Combination product: TACE-L-P

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 238

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with intermediate-advanced HCC beyond up-to-seven criteria and/or with PVTT.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SIRT-L-P; Patients were treated with SIRT-L-P	Combination product: SIRT-L-P; 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-P; Patients were treated with TACE-L-P	Combination product: TACE-L-P; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	the percentage of patients with complete or partial response according to mRECIST and RECIST 1.1	32 months
Overall survival	the time from the first SIRT or TACE until the date of all-cause mortality	32 months
Disease control rate (DCR)	the percentage of patients with complete, partial response, or stable disease according to mRECIST and RECIST 1.1	32 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University
• Collaborators: Hainan Cancer Hospital; Jinshazhou Hospital of Guangzhou University of Chinese Medicine; First Affiliated Hospital of Army Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; lenvatinib; transarterial chemoembolization; selective internal radiation therapy; PD-(L)1 Inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: MIIR-25-retro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No