Status:
COMPLETED
A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of Atezo+Bev plus Transarterial Chemoembolization (TACE) among adult patients with unresectabl...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Initiating both Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 regardless of sequencing, number of doses/cycles, and type of TACE
- At least one dose of Atezo+Bev and one cycle of TACE spaced no longer than 4 weeks
- Diagnosed with HCC and considered as unresectable by any of the below criteria:
- Predicted insufficient future liver remnant volume (FLRV) after liver resection, OR
- Predicted unattainable safe negative tumor margin resection, i.e., R0 resection, OR
- "Unresectable" directly documented in the medical records
- Exclusion Criteria:
- No visit record after initiating both Atezo+Bev and TACE
- Treated with other systemic therapy or resection against HCC
- Diagnosed with concomitant cancer except for basal cell carcinoma
- Advanced portal vein tumor thrombosis (PVTT) as defined by: Grade Vp 4, Cheng's Classification Type III or IV, or presence of a tumor thrombus in the main trunk of the portal vein, a portal vein branch contralateral to the primarily involved lobe, or superior mesenteric vein
- China Liver Cancer (CNLC) Stage IIIb, or history of extrahepatic metastasis
- Terminal-stage HCC
Exclusion
Key Trial Info
Start Date :
July 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT06503250
Start Date
July 19 2024
End Date
November 27 2024
Last Update
March 21 2025
Active Locations (5)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China, 510080
2
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China, 510630
3
Zhongshan Hospital Fudan University
Shanghai, China, 200032
4
Tianjin First Central Hospital
Tianjin, China, DUMMY_VALUE