SIRT or TACE Plus Lenvatinib and PD-(L)1 Inhibitor in High Burden HCC
NCT06916546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 238
Last updated 2025-04-08
Summary
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.
Conditions
- Hepatocellular Carcinoma Non-resectable
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
collaborator UNKNOWN -
First Affiliated Hospital of Army Military Medical University
collaborator UNKNOWN -
Hainan Cancer Hospital
collaborator OTHER -
Second Affiliated Hospital of Guangzhou Medical University
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2025-01-31
- Completion
- 2025-01-31
Countries
- China
Study Locations
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