Efficacy and Safety of SIRT-Y90 in Combination With Atezo + Bev for Unresectable Hepatocellular Carcinoma

May 20, 2026 updated by: Guohong Han, Air Force Military Medical University, China
This study adopted a bidirectional cohort study design. On the one hand, the previous clinical data, treatment exposure and clinical endpoint events of the enrolled patients were retrospectively collected. On the other hand, prospective regular follow-up was conducted from the date of enrollment to continuously observe long-term recurrence, progression and survival outcomes, and analyze the correlation between related factors and prognosis. The primary objective of this study was to describe the efficacy and safety of SIRT-Y90 in combination with atezolizumab and bevacizumab in adult patients with unresectable HCC in China. Medical records from approximately eight sites in China will be used.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria:

Age ≥18 years old A diagnosis of unresectable HCC was made. HCC can be diagnosed clinically or pathologically.

At least one Atezo plus Bev administration and one cycle of SIRT-Y90 treatment. At least one visit was recorded after the initiation of Atezo + Bev and SIRT-Y90

Exclusion criteria:

Concomitant cancers other than BCC were diagnosed before or at the start of Atezo + Bev or SIRT-Y90 Participate in an interventional clinical study before or at the time of initiation of treatment with Atezo + Bev or SIRT-Y90 Primary endpoint Objective response rate: defined as the percentage of patients who had a complete response (CR) or partial response (PR) at the follow-up date. If multiple response assessments were available within that time frame, the best overall response (BOR) was applied. Both RECIST 1.1 and mRECIST will be used to assess tumor response Solution. Secondary Endpoints Progression-Free Survival(PFS): Defined as the time from the index date to disease progression or death from any cause, whichever occurs first. Patients with unknown progression or death will be right-censored at the end of follow-up.

Overall Survival(OS): Defined as the time from the index date to death from any cause. Patients with unknown death will be right-censored at the end of follow-up.

Serum Alpha-Fetoprotein (AFP) Reduction: Serum AFP reduction is defined as a >50% decrease in AFP levels compared to baseline serum AFP levels, measured 3 months (±4 weeks) after initiation of Atezo + Bev or SIRT-Y90 treatment, whichever occurs later. The serum AFP level closest to the target time point will be used.

Adverse Events: Secondary variables/outcomes related to safety will be assessed based on actual medical records. Any adverse events (AEs) extracted from the medical records will be collected. Particular attention will be given to radiation-related AEs and immune-related AEs (irAEs).

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanxi
      • Xi’an, Shanxi, China, 710000
        • Recruiting
        • No. 777, Xitai Road, Chang'an District, Xi'an City, Shaanxi Province, China
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)

Description

Inclusion Criteria:

  • Age ≥18 years old A diagnosis of unresectable HCC was made. HCC can be diagnosed clinically or pathologically.

At least one Atezo plus Bev administration and one cycle of SIRT-Y90 treatment. At least one visit was recorded after the initiation of Atezo + Bev and SIRT-Y90

Exclusion Criteria:

  • Concomitant cancers other than BCC were diagnosed before or at the start of Atezo + Bev or SIRT-Y90 Participate in an interventional clinical study before or at the time of initiation of treatment with Atezo + Bev or SIRT-Y90

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
Intervention / Treatment
Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including s
Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
Drug: Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
Device: Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Follow-up is expected for one year.
defined as the percentage of patients who had a complete response (CR) or partial response (PR) at the follow-up date. If multiple response assessments were available within that time frame, the best overall response (BOR) was applied. Both RECIST 1.1 and mRECIST will be used to assess tumor response Solution.
Follow-up is expected for one year.

Collaborators and Investigators

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

Sponsor

Air Force Military Medical University, China

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)

February 9, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIRTAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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