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NCT Number: NCT07109336

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

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.

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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
  • 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

Exclusion criteria

  • • 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
  • 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

Treatment and study plan

Heterogeneous Treatment Effect-Based Decision Model

Device

Heterogeneous Treatment Effect-Based Decision Model

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

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

  2. 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

    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.

  3. 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

    defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first).

  4. TTP

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

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

  5. EHS

    Time frame: From index date to the first evidence of Extrahepatic Spread, assessed up to 10 months

    defined as the time from index date to the first evidence of Extrahepatic Spread.

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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