HCC - Hepatocellular CarcinomaNCT07109336
Development and Prospective Validation of a Heterogeneous Treatment Effect-Based Decision Model for Transarterial Chemoembolization Combined With or Without Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
A study testing Heterogeneous Treatment Effect-Based Decision Model in people with HCC - Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
Unresectable hepatocellular carcinoma (uHCC) constitutes a significant health burden in the Asia-Pacific (APAC) region, particularly in China, where it is frequently associated with hepatitis B virus (HBV) infection and diagnosed at advanced stages. 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?
- Heterogeneous Treatment Effect-Based Decision Model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- • Aged≥18 years
- Initiated first-line Atezo+Bev.
- Eligible for TACE treatment or received at least one TACE within ±2 months of Atezo+Bev initiation (before Atezo+Bev start, anytime during Atezo+Bev therapy, or after Atezo+Bev discontinuation).
- Clinically or pathologically diagnosed uHCC before or at the initiation of Atezo/Bev.The evidence of being diagnosed as "unresectable" may include but is not limited to below:
- "Unresectable" or "advanced" directly documented in the medical records History of extrahepatic metastasis as evidenced clinically or by radiology, histology or cytology OR China Liver Cancer (CNLC) Stage IIIb
- At least one visit record after the initiation of Atezo+Bev
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- No prior systemic therapy for HCC, especially immunotherapy
- No prior locoregional therapy to the target lesion(s)
- At least one measurable untreated lesion
- ECOG Performance Status of 0-2
Who cannot join
- • Evidence of extrahepatic spread (EHS)
- Participating in interventional clinical trials.
- Being a candidate for curative treatments
- Any condition representing a contraindication to TACE as determined by the investigators
- Active or history of autoimmune disease or immune deficiency
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding
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- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- Evidence of bleeding diathesis or significant coagulopathy
- Missing critical baseline or outcome data
Trial locations and contacts
1 site in 1 country.
About this study
Unresectable hepatocellular carcinoma (uHCC) constitutes a significant health burden in the Asia-Pacific (APAC) region, particularly in China, where it is frequently associated with hepatitis B virus (HBV) infection and diagnosed at advanced stages.
Transarterial chemoembolization (TACE) remains the standard treatment for intermediate-stage hepatocellular carcinoma (HCC), though its effectiveness diminishes in unresectable HCC (uHCC) with intermediate-to-high tumor burden. The IMbrave150 trial established atezolizumab plus bevacizumab (Atezo+Bev) as a superior alternative to sorafenib, demonstrating significant survival advantages in uHCC. Given the marked heterogeneity of intermediate-stage HCC, TACE may not benefit all patients equally. The TALENTACE study investigated on-demand TACE combined with Atezo+Bev versus TACE alone in treatment-naïve uHCC patients with intermediate-to-high tumor burden across China and Japan. Results revealed a statistically significant and clinically meaningful improvement in the primary endpoint, TACE- progression-free survival (PFS), though overall survival (OS) remained immature at the time of analysis.
This situation establishes a critical and unmet need for randomized controlled trials (RCTs) combined with extensive real-world evidence (RWE) to facilitate the assessment of individualized treatment heterogeneity and provide precise treatment recommendations in China and select Asia-Pacific regions.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Heterogeneous Treatment Effect-Based Decision Model
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heterogeneous Treatment Effect-Based Decision ModelDevice
Heterogeneous Treatment Effect-Based Decision Model
| Study group | Role | What they receive |
|---|---|---|
| Heterogeneous Treatment Effect-Based Decision Model | Active comparator | Participations receiving TACE alone or TACE combined with Atezolizumab plus Bevacizumab decsided by Heterogeneous Treatment Effect-Based Decision Model Receives: Device: Heterogeneous Treatment Effect-Based Decision Model |
| TACE combined with Atezolizumab plus Bevacizumab | Active comparator | Participations all receiving TACE combined with Atezolizumab plus Bevacizumab Receives: Device: Heterogeneous Treatment Effect-Based Decision Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
defined as time from index date to death from any cause.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (5)
TACE-PFS
defined as the time from index date to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first.
Measured: From index date to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first, assessed up to 10 months
PFS
defined as the time from index date to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 or mRECIST.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
DoR
defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first).
Measured: From the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), assessed up to 10 months
TTP
defined as the time from index date to unTACE able progression or TACE failure/refractoriness (as defined above).
Measured: From index date to unTACE able progression or TACE failure/refractoriness (as defined above), assessed up to 10 months
EHS
defined as the time from index date to the first evidence of Extrahepatic Spread.
Measured: From index date to the first evidence of Extrahepatic Spread, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026
- Study completion30 Aug 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Lu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109336
- Sponsor's protocol ID
- ISMIO2501
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Prospective Validation of a Heterogeneous Treatment Effect-Based Decision Model for Transarterial Chemoembolization Combined With or Without Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07109336
- Acronym / sponsor ID
- ISMIO2501
- Conditions
- HCC - Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 7 Aug 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.
Unresectable hepatocellular carcinoma (uHCC) constitutes a significant health burden in the Asia-Pacific (APAC) region, particularly in China, where it is frequently associated with hepatitis B virus (HBV) infection and diagnosed at advanced stages.
Transarterial chemoembolization (TACE) remains the standard treatment for intermediate-stage hepatocellular carcinoma (HCC), though its effectiveness diminishes in unresectable HCC (uHCC) with intermediate-to-high tumor burden. The IMbrave150 trial established atezolizumab plus bevacizumab (Atezo+Bev) as a superior alternative to sorafenib, demonstrating significant survival advantages in uHCC. Given the marked heterogeneity of intermediate-stage HCC, TACE may not benefit all patients equally. The TALENTACE study investigated on-demand TACE combined with Atezo+Bev versus TACE alone in treatment-naïve uHCC patients with intermediate-to-high tumor burden across China and Japan. Results revealed a statistically significant and clinically meaningful improvement in the primary endpoint, TACE- progression-free survival (PFS), though overall survival (OS) remained immature at the time of analysis.
This situation establishes a critical and unmet need for randomized controlled trials (RCTs) combined with extensive real-world evidence (RWE) to facilitate the assessment of individualized treatment heterogeneity and provide precise treatment recommendations in China and select Asia-Pacific regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heterogeneous Treatment Effect-Based Decision Model | Active comparator | Device: Heterogeneous Treatment Effect-Based Decision ModelParticipations receiving TACE alone or TACE combined with Atezolizumab plus Bevacizumab decsided by Heterogeneous Treatment Effect-Based Decision Model |
| TACE combined with Atezolizumab plus Bevacizumab | Active comparator | Device: Heterogeneous Treatment Effect-Based Decision ModelParticipations all receiving TACE combined with Atezolizumab plus Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Aged≥18 years
- "Unresectable" or "advanced" directly documented in the medical records History of extrahepatic metastasis as evidenced clinically or by radiology, histology or cytology OR China Liver Cancer (CNLC) Stage IIIb
- At least one visit record after the initiation of Atezo+Bev
- No prior systemic therapy for HCC, especially immunotherapy
- No prior locoregional therapy to the target lesion(s)
Key exclusion criteria (9 listed)
- • Evidence of extrahepatic spread (EHS)
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 |
|---|---|---|
| Heterogeneous Treatment Effect-Based Decision ModelHeterogeneous Treatment Effect-Based Decision Model | Device | Heterogeneous Treatment Effect-Based Decision Model, TACE combined with Atezolizumab plus Bevacizumab |
Primary outcome
Overall survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
defined as time from index date to death from any cause.
5 secondary outcomes
TACE-PFS
Time frame: From index date to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first, assessed up to 10 months
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
DoR
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), assessed up to 10 months
TTP
Time frame: From index date to unTACE able progression or TACE failure/refractoriness (as defined above), assessed up to 10 months
EHS
Time frame: From index date to the first evidence of Extrahepatic Spread, assessed up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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?
A study testing Heterogeneous Treatment Effect-Based Decision Model in people with HCC - 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months). 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 4 Sep 2026.