A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
- Cancer
- Hepatocellular Carcinoma (HCC)
Active, not recruiting
- Aichi
- Anhui
- Beijing
- Beijing City
- Changsha City
- Chengdu
- Chiba
- Chongqing
- Fukuoka
- Fuzhou
- Fuzhou City
- Guangzhou
- Hangzhou
- Harbin City
- Hiroshima
- Kanagawa
- Nanjing
- Nanjing City
- Nanning
- Osaka
- Shanghai
- Shenyang
- Tianjin City
- Tokyo
- Xi'an
- Zhengzhou Shi
NCT04712643 ML42612
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.
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
Eligibility 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
- 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
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