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

NCT04712643

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Hepatocellular Carcinoma

Interventions: Atezolizumab, Becavizumab, Transarterial chemoembolization (TACE)

Countries: China, Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (40)

Anhui, China
Beijing, China
Beijing, China
Beijing, China
Beijing, China
Changsha, China
Chengdu, China
Chongqing, China
Chongqing, China
Fuzhou, China
Fuzhou, China
Fuzhou, China
Fuzhou, China
Guangzhou, China
Guangzhou, China
Hangzhou, China
Harbin, China
Nanjing, China
Nanjing, China
Nanning, China
Nanning, China
Shanghai, China
Shanghai, China
Shanghai, China
Shenyang, China
Tianjin, China
Xi'an, China
Xi'an, China
Zhengzhou, China
Zhuhai, China
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