Hepatocellular Carcinoma Non-resectable
Conditions
Keywords
hepatocellular carcinoma, selective internal radiation therapy, transarterial chemoembolization, lenvatinib, PD-(L)1 Inhibitor
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.
Interventions
COMBINATION_PRODUCTTACE-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.
COMBINATION_PRODUCTSIRT-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.
Sponsors
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
First Affiliated Hospital of Army Military Medical University
Hainan Cancer Hospital
Second Affiliated Hospital of Guangzhou Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 32 months | the percentage of patients with complete or partial response according to mRECIST and RECIST 1.1 |
| Overall survival | 32 months | the time from the first SIRT or TACE until the date of all-cause mortality |
| Disease control rate (DCR) | 32 months | the percentage of patients with complete, partial response, or stable disease according to mRECIST and RECIST 1.1 |
Countries
China
Outcome results
None listed