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A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy

A Phase IIIb, Single Arm, Multicenter Study of Atezolizumab in Combination With Bevacizumab to Investigate Safety and Efficacy in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy

NCT04732286•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a Phase IIIb, one arm, multicenter, open-label study primarily designed to evaluate the safety of atezolizumab + bevacizumab in participants with unresectable or unsuitable for locoregional treatments for metastatic HCC not previously treated with systemic therapy. As part of its secondary objectives, this study is also designed to evaluate the efficacy of atezolizumab and bevacizumab in these participants.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or radiologically, following the AASLD criteria
•Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
•No prior systemic therapy (including systemic investigational agents) for HCC
•At least one measurable (per RECIST 1.1) untreated lesion detected by CT scan
•Patients who received prior local therapy such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization (excluding transarterial radioembolization.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1

Exclusion Criteria

•Active or history of autoimmune disease or immune deficiency
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
•Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
•Co-infection of HBV and HCV

Locations (25)

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Provincial de Castellon

Castellon, Castellon, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, Spain

Hospital de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, LAS Palmas, Spain

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, Spain

Clinica Universitaria de Navarra

Pamplona/iruña, Navarre, Spain

Hospital de Basurto

Bilbao, Vizcaya, Spain

Key Dates

Start Date

May 4, 2021

Primary Completion Date

April 26, 2024

Completion Date

April 26, 2024

Last Updated

May 8, 2025

Enrollment

100

ACTUAL participants

Conditions

Carcinoma, Hepatocellular

Interventions

Atezolizumab

DRUG

Bevacizumab

DRUG

Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

NCT06454578

Carcinoma, Hepatocellular

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RECRUITING

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy

Inclusion Criteria

Exclusion Criteria

Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

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