Clinical trial NCT06916546: SIRT or TACE Plus Lenvatinib and PD-(L)1 Inhibitor in High Burden HCC
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: hepatocellular carcinoma
selective internal radiation therapy
transarterial chemoembolization
lenvatinib
PD-(L)1 Inhibitor
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Jinshazhou Hospital of Guangzhou University of Chinese Medicine
name: First Affiliated Hospital of Army Military Medical University
name: Hainan Cancer Hospital
First posted: 2025-04-08
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermediate-advanced HCC beyond up-to-seven criteria and/or with PVTT.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 32 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 32 months
measure: Overall survival
timeFrame: 32 months
measure: Disease control rate (DCR)
timeFrame: 32 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: