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A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Hepatocellular Carcinoma

Phase 3
Conditions
Intermediate stage HCC
Registration Number
JPRN-jRCT2061200051
Lead Sponsor
idan Bai
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
342
Inclusion Criteria

onfirmed 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 Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy<br>Observation/medical examination, RECIC
Secondary Outcome Measures
NameTimeMethod
Safety, Efficacy<br>Observation/medical examination, RECIC
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