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

JRCT ID: jRCT2051210125

Registered date:24/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intermediate-stage HepatoCellular Carcinoma
• Date of first enrollment: 24/11/2021
• Target sample size: 56
• Countries of recruitment: South Korea,Japan,Taiwan,Japan,Spain,Japan,France,Japan,Italy,Japan,Germany,Japan,Austria,Japan
• Study type: Interventional

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] )

Outcome(s)

• Primary Outcome: Time to failure of treatment strategy(TTFS[assessed every 8 weeks]

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include 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

Exclude 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)

Related Information

• Primary Sponsor: Kudo Masatoshi
• Secondary ID(s): NCT04803994,2020-004210-35