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

JRCT ID: jRCT2061200051

Registered date:02/02/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Intermediate stage HCC
• Date of first enrollment: 22/06/2021
• Target sample size: 342
• Countries of recruitment: China,Japan
• Study type: Interventional

Intervention(s)

atezolizumab: 1200 mg by intravenous infusion on Day 1 of each 21-day cycle
bevacizumab: 15 mg/kg by intravenous infusion on Day 1 of each 21-day cycle

Outcome(s)

Primary Outcome

Efficacy
Observation/medical examination, RECICL

Secondary Outcome

Safety, Efficacy
Observation/medical examination, RECICL

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Lidan Bai
• Secondary ID(s): NCT04712643