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Active Not Recruiting
NCT04712643
A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 342
Sponsor: Hoffmann-La Roche
Location: Anhui Provincial Hospital Anhui
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
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
Source: ClinicalTrials.gov (NCT04712643). StuddyBuddy aggregates publicly available trial information.