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

NCT ID: NCT07109336

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 790 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-01-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heterogeneous Treatment Effect-Based Decision Model

Participations receiving TACE alone or TACE combined with Atezolizumab plus Bevacizumab decsided by Heterogeneous Treatment Effect-Based Decision Model

Group Type: ACTIVE_COMPARATOR

Heterogeneous Treatment Effect-Based Decision Model

Intervention Type: DEVICE

Heterogeneous Treatment Effect-Based Decision Model

TACE combined with Atezolizumab plus Bevacizumab

Participations all receiving TACE combined with Atezolizumab plus Bevacizumab

Group Type: ACTIVE_COMPARATOR

Heterogeneous Treatment Effect-Based Decision Model

Intervention Type: DEVICE

Heterogeneous Treatment Effect-Based Decision Model

Interventions

Heterogeneous Treatment Effect-Based Decision Model

Heterogeneous Treatment Effect-Based Decision Model

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Lu

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ISMIO2501

Identifier Type: -

Identifier Source: org_study_id