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.
Signed Informed Consent Form available
Patients* ≥ 18 years of age at time of signing Informed Consent Form
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, liver transplantation or curative ablation BUT disease amenable to TACE at enrollment as judged by the investigator.
No extrahepatic disease Note: Patients with HCC beyond Milan criteria who enter a downstaging protocol may be recruited into the trial if they do not present any exclusion criteria.
Patients with recurrence after resection/ablation or after previous TACE are eligible, if they - according to the investigator - have an indication for (additional) TACE
Child-Pugh score class A or B7 without ascites requiring more than 100 mg of spironolactone/day (see exclusion criteria) at enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at enrollment.
Parallel
Atezolizumab
Drug1200 mg atezolizumab intravenously Q3W (max 32 cycles, up to 24 months)
Bevacizumab
Drug15 mg/kg intravenously Q3W (max 32 cycles, up to 24 months)
TACE
Procedure/SurgeryLocoregional therapy will be performed as a standard-of-care procedure
Time to failure of treatment strategy
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.
Overall survival (OS)
Time from the date of randomization until the date of death due to any cause. A subject who has not died will be censored at last known date alive.
Overall Survival Rate at 24 months (OS@24)
The proportion of patients assigned to a treatment arm known to be alive at 24 months after randomization.
Objective Response Rate (ORR)
The proportion of patients assigned to a treatment arm with a confirmed best response of Complete Response (CR) or Partial Response (PR). Response will be assessed according to HCC mRECIST.
Time to Progression (TTP)
Time from the date of randomization until the date of first objective disease progression. Subjects who have not progressed will be censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. Subjects who die without experiencing a progress first will be censored on their date of death.
Exploratory endpoint - Correlation of biomarkers for study endpoints
Tissue, blood and stool samples will be collected to identify prognostic and predictive angiogenic and immune related biomarkers (tissue and circulating) for study endpoints.
Exploratory endpoint - PD-L1 expression
PD-L1 expression will be analyzed by immunohistochemistry on available FFPE tissue samples
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