A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504303-86-00

Acronym

WO41535

Enrollment

Registered

2024-06-12

Start date

2019-11-21

Completion date

Unknown

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk hepatocellular carcinoma (HCC)

Brief summary

1. Independent Review Facility (IRF)-assessed recurrence-free survival (RFS)

Detailed description

1. Overall Survival (OS) rate at 24 months and 36 months, 2. OS, 3. RFS as determined by the investigator, 4. Time to Recurrence (TTR), 5. Time to extrahepatic spread (EHS) or macrovascular invasion, 6. RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup, 7. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0, 8. Change from baseline in targeted vital signs, 9. Change from baseline in targeted clinical laboratory test results, 10. Serum concentration of atezolizumab at specified timepoints, 11. Prevalence of anti-drug antibody (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study, 12. IRF-assessed RFS and investigator-assessed RFS rate at 24 and 36 months after randomization

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Independent Review Facility (IRF)-assessed recurrence-free survival (RFS)	—

Secondary

Measure	Time frame
1. Overall Survival (OS) rate at 24 months and 36 months, 2. OS, 3. RFS as determined by the investigator, 4. Time to Recurrence (TTR), 5. Time to extrahepatic spread (EHS) or macrovascular invasion, 6. RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup, 7. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0, 8. Change from baseline in targeted vital signs, 9. Change from baseline in targeted clinical laboratory test results, 10. Serum concentration of atezolizumab at specified timepoints, 11. Prevalence of anti-drug antibody (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study, 12. IRF-assessed RFS and investigator-assessed RFS rate at 24 and 36 months after randomization	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026