A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516479-34-00

Acronym

XL184-312

Enrollment

Registered

2024-10-14

Start date

2019-05-17

Completion date

Unknown

Last updated

2025-11-04

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

Conditions

Hepatocellular carcinoma

Brief summary

Duration of Progression Free Survival (PFS) per RECIST 1.1, by Blinded Independent Radiology Committee (BIRC) for the experimental arm (cabozantinib+atezolizumab) vs the control arm ( sorafenib), Duration of Overall Survival (OS) for the experimental arm (cabozantinib+atezolizumab) vs the control arm (sorafenib)

Detailed description

PFS per RECIST 1.1 by BIRC for the single-agent cabozantinib arm vs the control arm (sorafenib)

Interventions

DRUGNexavar 200 mg film-coated tablets

DRUGCABOMETYX 20 mg film-coated tablets

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGCABOMETYX 60 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Duration of Progression Free Survival (PFS) per RECIST 1.1, by Blinded Independent Radiology Committee (BIRC) for the experimental arm (cabozantinib+atezolizumab) vs the control arm ( sorafenib), Duration of Overall Survival (OS) for the experimental arm (cabozantinib+atezolizumab) vs the control arm (sorafenib)	—

Secondary

Measure	Time frame
PFS per RECIST 1.1 by BIRC for the single-agent cabozantinib arm vs the control arm (sorafenib)	—

Countries

Belgium, France, Hungary, Romania, Spain

Outcome results

None listed

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