The ABC-HCC Trial: A Phase IIIb, Randomized, Multicenter, Open-label Trial of Atezolizumab Plus Bevacizumab Versus Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma

NCT04803994 Phase 3 RECRUITING

The ABC-HCC trial is a Phase IIIb, randomised, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC. Approximately 434 patients in two arms of treatment will be enrolled.

Details

Lead sponsor	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Phase	Phase 3
Status	RECRUITING
Enrolment	434
Start date	2021-07-06
Completion	2027-07

Conditions

• Hepatocellular Carcinoma

Interventions

• Atezolizumab
• Bevacizumab
• TACE

Primary outcomes

• Time to failure of treatment strategy — 48 months - assessed every 8 weeks (±7days)
  The primary endpoint is defined as the time from randomization until death or need for a further therapeutic option, defined for each arm as follows: * Arm A: Time from randomization until the failure of strategy does not allow for further treatment with atezolizumab + bevacizumab; or death, whichever comes first. * Arm B: Time from randomization until the failure of strategy does not allow for further TACE therapy; or death, whichever comes first. Failure of strategy (in brief): failure of strategy is reached in case of progressive disease accompanied by any of the following: loss of clinical benefit, unacceptable toxicity, liver function deterioration, therapy not further applicable for other reasons.

Countries

Austria, France, Germany, Italy, Japan, Spain