CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 434 target
Drug / intervention
Atezolizumab +2 moredrug
Likely dose
Atezolizumab 1200 mgfrom record
Key inclusion· 20
  • Age ≥18 years at time of signing ICF
  • Confirmed HCC diagnosis by histopathology or typical imaging (dynamic CT/MRI per AASLD criteria)
  • Intermediate-stage HCC not amenable to curative surgery/transplant/ablation but amenable to TACE
  • No massive multinodular pattern preventing adequate TACE
Key exclusion· 31
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC (if biopsy-proven)
  • Prior treatment with atezolizumab or bevacizumab
  • Prior PD-1, PD-L1, or CTLA-4 inhibitors or any cancer immunotherapy for HCC
  • Clinically meaningful ascites requiring non-pharmacologic intervention (paracentesis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04803994
NCT04803994Phase 3RecruitingHigh MomentumUpdated 17mo ago
Long Recruiting

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

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·interventional·Posted Mar 18, 2021·Updated Jan 7, 2025

In Brief

A Phase 3 clinical trial evaluating Atezolizumab, Bevacizumab, and 1 other intervention for Hepatocellular Carcinoma. Currently recruiting, targeting 434 participants across 72 sites in 6 countries.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, Germany, Italy, Japan, Spain
Collaborators--

Timeline

Phase 3Recruiting
202220232024202520262027
First PostedMar 18, 2021
Enrollment StartJul 6, 2021
Primary CompletionJul 1, 2027
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 5.3 years agoPrimary completion in 12 months

Interventions

Atezolizumabdrug

1200 mg atezolizumab intravenously Q3W (max 32 cycles, up to 24 months)

Bevacizumabdrug

15 mg/kg intravenously Q3W (max 32 cycles, up to 24 months)

TACEprocedure

Locoregional therapy will be performed as a standard-of-care procedure