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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

ConditionHCC - Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongda Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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).

At least one visit record after the initiation of Atezo+Bev

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Heterogeneous Treatment Effect-Based Decision Model

    Device

    Heterogeneous Treatment Effect-Based Decision Model

Treatment groups

790 Participants
are divided into 2 treatment groups
Group A: Heterogeneous Treatment Effect-Based Decision ModelActive comparator 1 intervention
Group B: TACE combined with Atezolizumab plus BevacizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

defined as time from index date to death from any cause.

Time frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes

1

TACE-PFS

defined as the time from index date to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first.

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
2

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.

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
3

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).

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
4

TTP

defined as the time from index date to unTACE able progression or TACE failure/refractoriness (as defined above).

Time frame
From index date to unTACE able progression or TACE failure/refractoriness (as defined above), assessed up to 10 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongda Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: