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

March 31, 2025 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • The second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SIRT-L-P
Patients were treated with SIRT-L-P
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.
TACE-L-P
Patients were treated with TACE-L-P
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
32 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 32 months
the percentage of patients with complete or partial response according to mRECIST and RECIST 1.1
32 months
Overall survival
Time Frame: 32 months
the time from the first SIRT or TACE until the date of all-cause mortality
32 months
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
32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Guangzhou Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hainan Cancer Hospital
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
First Affiliated Hospital of Army Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MIIR-25-retro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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