Status:
ACTIVE_NOT_RECRUITING
A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- Eligible for TACE treatment
- 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 0-1
- Child-Pugh class A
Exclusion
- Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT)
- Evidence of extrahepatic spread (EHS)
- 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
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2029
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT04712643
Start Date
March 12 2021
End Date
February 1 2029
Last Update
October 31 2025
Active Locations (40)
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1
Anhui Provincial Hospital
Anhui, China, 230001
2
Peking University First Hospital
Beijing, China, 100034
3
Peking University People's Hospital
Beijing, China, 100044
4
Beijing You An Hospital
Beijing, China, 100069