A Phase 3b,randomized,multicenter,open-label trial of Atezolizumab plus Bevacizumab versus transarterial Chemoembolization(TACE) in intermediate-stage HepatoCellular Carcinoma
- Conditions
- Intermediate-stage HepatoCellular Carcinoma
- Registration Number
- JPRN-jRCT2051210125
- Lead Sponsor
- Kudo Masatoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to failure of treatment strategy(TTFS[assessed every 8 weeks]
- Secondary Outcome Measures
Name Time Method Overall Survival<br>Overall Survival Rate at 24 months<br>Objective Response Rate<br>Time to Progression<br>Time to loss of systemic treatment options<br>Progression free survival<br>Duration of Treatment<br>Duration of Response<br>Time to deterioration of liver function<br>Safety<br>Qo