NCT06916546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

March 31, 2025

Last Update Submit

March 31, 2025

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

hepatocellular carcinomaselective internal radiation therapytransarterial chemoembolizationlenvatinibPD-(L)1 Inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Objective response rate (ORR)

    32 months

  • Overall survival

    32 months

  • Disease control rate (DCR)

    32 months

Study Arms (2)

SIRT-L-P

Patients were treated with SIRT-L-P

Combination Product: SIRT-L-P

TACE-L-P

Patients were treated with TACE-L-P

Combination Product: TACE-L-P

Interventions

SIRT-L-PCOMBINATION_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.

SIRT-L-P
TACE-L-PCOMBINATION_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.

TACE-L-P

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 8, 2025

Study Start

June 1, 2022

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

April 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)