NCT07610551

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
Feb 2022Dec 2026

Study Start

First participant enrolled

February 9, 2022

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

4.8 years

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Keywords

Hepatocellular CarcinomaSIRT-Y90AtezolizumabBevacizumab

Outcome Measures

Primary Outcomes (1)

  • 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.

    Follow-up is expected for one year.

Study Arms (1)

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

Interventions

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 s

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 777, Xitai Road, Chang'an District, Xi'an City, Shaanxi Province, China

Xi’an, Shanxi, 710000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Participants included will have peripheral blood samples collected at different time points.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumabBevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

GuoHong Han, Doctor of Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 28, 2026

Study Start

February 9, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations