HCC - Hepatocellular CarcinomaNCT07610551
Efficacy and Safety of SIRT-Y90 in Combination With Atezo + Bev for Unresectable Hepatocellular Carcinoma
An observational study of HCC - Hepatocellular Carcinoma, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2022to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No. 777, Xitai Road, Chang'an District, Xi'an City, Shaanxi Province, China
Xi’an, Shanxi, 710000
Guohong Han, Doctor of Medicine, 18234507085 ext. +86, yingxiangZYL@163.com
About this study
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.
Read the 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).
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
- Keywords
- Hepatocellular Carcinoma, SIRT-Y90, Atezolizumab, Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow-up is expected for one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start9 Feb 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610551
- Sponsor's protocol ID
- SIRTAB
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SIRT-Y90 in Combination With Atezo + Bev for Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07610551
- Acronym / sponsor ID
- SIRTAB
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, SIRT-Y90, Atezolizumab, Bevacizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including s | – | 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)Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable HCC patients receiving SIRT-Y90 combined with atezolizumab and bevacizumab (including some patients who received only SIRT-Y90 treatment)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | 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)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 s |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GuoHong Han, Doctor of Medicine (18234507085 ext. +86, yingxiangZYL@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Follow-up is expected for one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.