NCT03434379

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

Detailed description

The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
DRUG	Bevacizumab	Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
DRUG	Sorafenib	Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-08-31
• Completion: 2022-11-17
• First posted: 2018-02-15
• Last updated: 2023-10-23
• Results posted: 2021-11-05

Locations

119 sites across 17 countries: United States, Australia, Canada, China, Czechia, France, Germany, Hong Kong, Italy, Japan, Poland, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study