Status:
TERMINATED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04732286
Start Date
May 4 2021
End Date
April 26 2024
Last Update
May 8 2025
Active Locations (25)
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1
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
2
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain, 07198
3
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
4
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008