NIPH Clinical Trials Search

JRCT ID: jRCT2051210125

Registered date:24/11/2021

A Phase 3b,randomized,multicenter,open-label trial of Atezolizumab plus Bevacizumab versus transarterial Chemoembolization(TACE) in intermediate-stage HepatoCellular Carcinoma

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedIntermediate-stage HepatoCellular Carcinoma
Date of first enrollment24/11/2021
Target sample size56
Countries of recruitmentSouth Korea,Japan,Taiwan,Japan,Spain,Japan,France,Japan,Italy,Japan,Germany,Japan,Austria,Japan
Study typeInterventional
Intervention(s)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 TACE [cTACE] or drug-eluting bead TACE [DEB-TACE] )


Primary OutcomeTime to failure of treatment strategy(TTFS[assessed every 8 weeks]
Secondary OutcomeOverall 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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteriaConfirmed 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
Exclude criteriaKnown 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)

Related Information


Public contact
Name Hiroshi Miyamoto
Address Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka Osaka Japan 530-0044
Telephone +81-6-6358-7110
Affiliation FIVERINGS CO.,LTD.
Scientific contact
Name Masatoshi Kudo
Address 377-2 Ohnohigashi,Osaka-Sayama City,Osaka Osaka Japan 589-8511
Telephone +81-72-366-0221
Affiliation Kindai University Hospital