CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 837 enrolled
Drug / intervention
Cabozantinib +3 moredrug
Likely dose
Cabozantinib 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03755791
NCT03755791Phase 3Active
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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

Exelixis·interventional·Posted Nov 28, 2018·Updated Dec 11, 2025

In Brief

A Phase 3 clinical trial evaluating Cabozantinib, Sorafenib, and 1 other intervention for Hepatocellular Carcinoma. Active but no longer recruiting, targeting 837 participants across 245 sites in 34 countries.

Detailed Summary

This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which participants receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, France, Georgia, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20192020202120222023202420252026
First PostedNov 28, 2018
Enrollment StartJun 10, 2018
Primary CompletionNov 30, 2021
Study CompletionJul 31, 2026
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.6 years ago

Interventions

Cabozantinibdrug

Supplied as 20-mg tablets; administered orally daily at 40 mg

Cabozantinibdrug

Supplied as 60-mg tablets; administered orally once daily at 60 mg

Sorafenibdrug

Supplied as 200-mg tablets; administered orally twice daily at 400 mg

Atezolizumabdrug

Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w