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

NCT03434379 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2023-10-23

Study results available
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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.

Conditions

  • Carcinoma, Hepatocellular

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2020-08-31
Completion
2022-11-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434379 on ClinicalTrials.gov