Intermediate-stage HepatoCellular Carcinoma
Conditions
Interventions
Arm: A
Atezolizumab 1200mg intraveneous(IV) infusions Q3W(dosed in 3-week cycles) plus Bevacizumab 15 mg/kg IV Q3W(dosed in 3-week cycles)
Arm: B
Transarterial Chemoembolization(using conventional TAC
Sponsors
Kudo Masatoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmed hepatocellular carcinoma diagnosis based on histopathological findings from tumor tissue or typical diagnostic imaging on dynamic CT or MRI according to AASLD criteria Disease not amenable to curative surgery or transplantation (for exceptions refer to inclusion criterion #5) or curative ablation BUT disease amenable to TACE at enrollment. Intermediate stage HCC No main portal vein invasion/thrombosis on baseline/eligibility imaging. Patients with minimal invasion, (Vp1 and Vp2) may be eligible if no exclusion criteria are violated. Child-Pugh score class A or B7 without ascites requiring more than 100 mg of spironolactone/day
Exclusion criteria
Exclusion criteria: Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC (only if proven by biopsy). Disease still amenable to curative surgery or transplantation or curative ablation Previous treatment with atezolizumab or bevacizumab Previous local therapy (e.g. cryoablation, high-intensity focused ultrasound, irreversible electroporation) Evidence of macrovascular invasion on baseline/eligibility imaging. Patients with minimal invasion (Vp1 and Vp2) are eligible if no other Exclusion criteria are violated. Massive multinodular pattern preventing adequate TACE Extrahepatic disease Previous radiotherapy for HCC, but previous RFA is allowed (refer to inclusion criterion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to failure of treatment strategy(TTFS[assessed every 8 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Overall Survival Rate at 24 months Objective Response Rate Time to Progression Time to loss of systemic treatment options Progression free survival Duration of Treatment Duration of Response Time to deterioration of liver function Safety QoL | — |
Countries
Austria, France, Germany, Italy, Japan, South Korea, Spain, Taiwan
Contacts
Public ContactHiroshi Miyamoto
FIVERINGS CO.,LTD.
Outcome results
None listed