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Completed

NCT Number: NCT06916546

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Non-resectable Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SIRT-L-P

Combination 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-P

Combination 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.

Primary outcomes

  1. Progression-free survival

    Time frame: 32 months

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

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: 32 months

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

  2. Overall survival

    Time frame: 32 months

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

  3. Disease control rate (DCR)

    Time frame: 32 months

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
  • Hainan Cancer Hospital
  • Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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