A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Trial Identifier NCT04712643, ML42612

Condition Hepatocellular Carcinoma

Official Title A Phase III, Open-Label, Randomized Study of On-Demand TACE Combined With Atezolizumab Plus Bevacizumab (Atezo/Bev) or On-Demand TACE Alone in Patients With Untreated Heaptocellular Carcionma

Study 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 high risk of poorer outcome following TACE treatment.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

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 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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

For the latest version of this information please go to www.forpatients.roche.com