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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| TACE combined with Atezolizumab plus Bevacizumab | Active Comparator | Participations all receiving TACE combined with Atezolizumab plus Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heterogeneous Treatment Effect-Based Decision Model | Device | Heterogeneous Treatment Effect-Based Decision Model |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | defined as time from index date to death from any cause. | From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| TACE-PFS | defined as the time from index date to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first. | From index date to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first, assessed up to 10 months |
| PFS |
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Inclusion Criteria:
• 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
Exclusion Criteria:
• Evidence of extrahepatic spread (EHS)
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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. |
| 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). | 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). | 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. | From index date to the first evidence of Extrahepatic Spread, assessed up to 10 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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