Unresectable Hepatocellular CarcinomaISMIO001NCT07204327
Atezolizumab Plus Bevacizumab Combined With Locoregional Therapies in Unresectable Hepatocellular Carcinoma (ISMIO-001)
An observational study of Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
This is a retrospective, multicenter, real-world cohort study designed to evaluate the effectiveness and safety of atezolizumab plus bevacizumab (Atezo+Bev) combined with various locoregional therapies (LRTs), including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Atezo+Bev plus Locoregional Therapy
- Type of treatment
- Injection or infusion
- How many people
- 1,136 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2020to 31 Dec 2026
- 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: Patients with unresectable hepatocellular carcinoma (uHCC) treated in routine clinical practice across multiple centers in China and the Asia-Pacific region, receiving atezolizumab plus bevacizumab in combination with locoregional therapies.
Who may be able to join
- Age ≥18 years at initiation of atezolizumab plus bevacizumab (Atezo+Bev)
- Histologically or radiologically confirmed unresectable hepatocellular carcinoma (uHCC) according to national guidelines
- Initiated first-line Atezo+Bev treatment between October 28, 2020 and July 31, 2025
- Received ≥1 locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of Atezo+Bev initiation
- At least one follow-up record available after treatment initiation
Who cannot join
- Prior systemic therapy for HCC before Atezo+Bev initiation
- Concurrent participation in interventional clinical trials at baseline
- Diagnosis of other malignancies at baseline (except basal cell carcinoma of the skin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Atezolizumab + Bevacizumab Plus Locoregional Therapies in Patients With Unresectable Hepatocellular Carcinoma in Real-world Clinical Practice
This is a retrospective, multicenter, real-world cohort study designed to evaluate the effectiveness and safety of atezolizumab plus bevacizumab (Atezo+Bev) combined with various locoregional therapies (LRTs), including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE), ablation, and radiotherapy, in patients with unresectable hepatocellular carcinoma (uHCC). Approximately 1,136 patients treated between October 28, 2020 and October 31, 2025 will be included from about 35 sites across China and the Asia-Pacific region. The primary endpoint is overall survival (OS). Secondary endpoints include real-world progression-free survival (rwPFS), overall response rate (ORR), disease control rate (DCR), time to discontinuation (TTD), time to next treatment (TTNT), time to progression (TTP), and safety outcomes. Exploratory analyses will assess associations between baseline patient characteristics, treatment patterns, and clinical outcomes.
Read the detailed description
Hepatocellular carcinoma (HCC) is a major cause of cancer-related death worldwide, with a particularly high burden in China and the Asia-Pacific region, where chronic hepatitis B virus (HBV) infection is the predominant etiology. While atezolizumab plus bevacizumab (Atezo+Bev) has been established as the global first-line standard of care for unresectable HCC (uHCC), clinical trial populations were highly selective, excluding patients with impaired liver function or poor performance status, and the overall response rate remains limited at approximately 30%.
Locoregional therapies (LRTs) such as TACE, HAIC, TARE, ablation, and radiotherapy remain an integral part of uHCC management in the Asia-Pacific region, offering potential synergistic effects when combined with Atezo+Bev. However, there is a lack of robust real-world evidence describing the timing, sequencing, and outcomes of these combined strategies.
The ISMIO-001 study is designed as a retrospective, multicenter, real-world cohort study. Eligible patients must be ≥18 years old, diagnosed with uHCC, and treated with Atezo+Bev plus at least one LRT within ±2 months of Atezo+Bev initiation, between October 28, 2020 and July 31, 2025. The observation period will continue until October 31, 2025, with study completion anticipated by December 31, 2026.
The study will provide large-scale evidence on treatment patterns, overall survival, safety, and subgroup outcomes (e.g., by BCLC/CNLC stage, Child-Pugh class, ALBI grade, HBV vs. other etiologies). Findings will inform future clinical guidelines and support the optimization of treatment sequencing for uHCC in HBV-predominant populations.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Atezo+Bev plus Locoregional Therapy
- Keywords
- Unresectable Hepatocellular Carcinoma, Atezolizumab, Bevacizumab, Unresectable HCC, Locoregional Therapy, TACE, HAIC, TARE, Ablation, Real-world, HBV, Asia-Pacific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezo+Bev plus Locoregional TherapyOther
Patients received atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (transarterial chemoembolization [TACE], hepatic arterial infusion chemotherapy [HAIC], transarterial radioembolization [TARE], ablation, or radiotherapy) within ±2 months of systemic therapy initiation, in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| uHCC patients treated with Atezo+Bev plus LRT | Patients with unresectable hepatocellular carcinoma (uHCC) who received first-line atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of systemic therapy initiation, between October 28, 2020 and July 31, 2025. Receives: Other: Atezo+Bev plus Locoregional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival, defined as the time from initiation of atezolizumab plus bevacizumab treatment to death from any cause.
Measured: Up to 36 months (median follow-up period anticipated)
Secondary outcomes (7)
Real-world Progression-Free Survival (rwPFS)
Time from initiation of Atezo+Bev treatment to investigator-assessed disease progression (local progression, recurrence, new metastasis, or clinical progression) or death from any cause.
Measured: Up to 36 months
Objective Response Rate (ORR)
Proportion of patients with complete response (CR) or partial response (PR), as assessed by RECIST 1.1 and mRECIST criteria.
Measured: Up to 36 months
Disease Control Rate (DCR)
Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD ≥6 weeks), based on RECIST 1.1 or mRECIST.
Measured: Up to 36 months
Time to Treatment Discontinuation (TTD)
Time from treatment initiation to discontinuation of Atezo+Bev for any reason.
Measured: Up to 36 months
Time to Next Treatment (TTNT)
Time from initiation of Atezo+Bev to start of subsequent systemic therapy.
Measured: Up to 36 months
Time to Progression (TTP)
Time from initiation of Atezo+Bev to first documentation of disease progression.
Measured: Up to 36 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence and severity of all adverse events (AEs), treatment-related AEs (TRAEs), and adverse events of special interest (bleeding, hypertension, hepatic impairment, immune-related AEs).
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start28 Oct 2020
- Primary completion31 Oct 2025 (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 Unresectable 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
- Retrospective
- Enrolment
- 1,136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204327
- Sponsor's protocol ID
- CHANCE2510-ISMIO001
- Acronym
- ISMIO001
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Individual data sharing
- Undecided: Yes, de-identified IPD may be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Atezolizumab + Bevacizumab Plus Locoregional Therapies in Patients With Unresectable Hepatocellular Carcinoma in Real-world Clinical Practice
- ClinicalTrials.gov ID
- NCT07204327
- Acronym / sponsor ID
- ISMIO001 / CHANCE2510-ISMIO001
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Unresectable Hepatocellular Carcinoma, Atezolizumab, Bevacizumab, Unresectable HCC, Locoregional Therapy, TACE, HAIC, TARE
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,136 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (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 is a retrospective, multicenter, real-world cohort study designed to evaluate the effectiveness and safety of atezolizumab plus bevacizumab (Atezo+Bev) combined with various locoregional therapies (LRTs), including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE), ablation, and radiotherapy, in patients with unresectable hepatocellular carcinoma (uHCC). Approximately 1,136 patients treated between October 28, 2020 and October 31, 2025 will be included from about 35 sites across China and the Asia-Pacific region. The primary endpoint is overall survival (OS). Secondary endpoints include real-world progression-free survival (rwPFS), overall response rate (ORR), disease control rate (DCR), time to discontinuation (TTD), time to next treatment (TTNT), time to progression (TTP), and safety outcomes. Exploratory analyses will assess associations between baseline patient characteristics, treatment patterns, and clinical outcomes.
Detailed description
Hepatocellular carcinoma (HCC) is a major cause of cancer-related death worldwide, with a particularly high burden in China and the Asia-Pacific region, where chronic hepatitis B virus (HBV) infection is the predominant etiology. While atezolizumab plus bevacizumab (Atezo+Bev) has been established as the global first-line standard of care for unresectable HCC (uHCC), clinical trial populations were highly selective, excluding patients with impaired liver function or poor performance status, and the overall response rate remains limited at approximately 30%.
Locoregional therapies (LRTs) such as TACE, HAIC, TARE, ablation, and radiotherapy remain an integral part of uHCC management in the Asia-Pacific region, offering potential synergistic effects when combined with Atezo+Bev. However, there is a lack of robust real-world evidence describing the timing, sequencing, and outcomes of these combined strategies.
The ISMIO-001 study is designed as a retrospective, multicenter, real-world cohort study. Eligible patients must be ≥18 years old, diagnosed with uHCC, and treated with Atezo+Bev plus at least one LRT within ±2 months of Atezo+Bev initiation, between October 28, 2020 and July 31, 2025. The observation period will continue until October 31, 2025, with study completion anticipated by December 31, 2026.
The study will provide large-scale evidence on treatment patterns, overall survival, safety, and subgroup outcomes (e.g., by BCLC/CNLC stage, Child-Pugh class, ALBI grade, HBV vs. other etiologies). Findings will inform future clinical guidelines and support the optimization of treatment sequencing for uHCC in HBV-predominant populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uHCC patients treated with Atezo+Bev plus LRT | – | Other: Atezo+Bev plus Locoregional TherapyPatients with unresectable hepatocellular carcinoma (uHCC) who received first-line atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of systemic therapy initiation, between October 28, 2020 and July 31, 2025. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable hepatocellular carcinoma (uHCC) treated in routine clinical practice across multiple centers in China and the Asia-Pacific region, receiving atezolizumab plus bevacizumab in combination with locoregional therapies.
Key inclusion criteria (5 listed)
- Age ≥18 years at initiation of atezolizumab plus bevacizumab (Atezo+Bev)
- Histologically or radiologically confirmed unresectable hepatocellular carcinoma (uHCC) according to national guidelines
- Initiated first-line Atezo+Bev treatment between October 28, 2020 and July 31, 2025
- Received ≥1 locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of Atezo+Bev initiation
- At least one follow-up record available after treatment initiation
Key exclusion criteria (3 listed)
- Prior systemic therapy for HCC before Atezo+Bev initiation
- Concurrent participation in interventional clinical trials at baseline
- Diagnosis of other malignancies at baseline (except basal cell carcinoma of the skin)
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 |
|---|---|---|
| Atezo+Bev plus Locoregional TherapyPatients received atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (transarterial chemoembolization [TACE], hepatic arterial infusion chemotherapy [HAIC], transarterial radioembolization [TARE], ablation, or radiotherapy) within ±2 months of systemic therapy initiation, in routine clinical practice. | Other | uHCC patients treated with Atezo+Bev plus LRT |
Primary outcome
Overall Survival (OS)
Time frame: Up to 36 months (median follow-up period anticipated)
Overall survival, defined as the time from initiation of atezolizumab plus bevacizumab treatment to death from any cause.
7 secondary outcomes
Real-world Progression-Free Survival (rwPFS)
Time frame: Up to 36 months
Objective Response Rate (ORR)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Time to Treatment Discontinuation (TTD)
Time frame: Up to 36 months
Time to Next Treatment (TTNT)
Time frame: Up to 36 months
Time to Progression (TTP)
Time frame: Up to 36 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 36 months
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 2 Oct 2025.
- Individual participant dataSharing planned: Undecided. Yes, de-identified IPD may be shared upon reasonable request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 36 months (median follow-up period anticipated)). 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 2 Oct 2025.