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
Reason given: The study was completed as pre-specified in the protocol. Study was terminated only for participants who were in the study even after 24 months of follow-up as specified in the protocol.
Key facts
- Where
- Alicante, Almería, Barcelona, Bilbao, Castellon, Córdoba, Elche, Jaén, Las Palmas de Gran Canaria, Lugo, Madrid, Palma de Mallorca, Pamplona/iruña, Sabadell, Santander, Santiago de Compostela, Seville, Torrejón de Ardoz, Valencia, and Zaragoza, SpainSee the 25 sites
- Phase
- Phase 3
Where in Spain
- Hospital General Univ. de AlicanteAlicante, SpainNo longer taking part
- Complejo Hospitalario TorrecardenasAlmería, SpainNo longer taking part
- Hospital Clinic i ProvincialBarcelona, SpainNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpainNo longer taking part
- Hospital De BasurtoBilbao, SpainNo longer taking part
- Hospital Provincial de CastellónCastellon, SpainNo longer taking part
- Hospital Universitario Reina SofiaCórdoba, SpainNo longer taking part
- Hospital General Universitario de ElcheElche, SpainNo longer taking part
- Complejo Hospitalario de Jaen-Hospital Universitario Medico QuirurgicoJaén, SpainNo longer taking part
- Hospital de Gran Canaria Dr. NegrínLas Palmas de Gran Canaria, SpainNo longer taking part
- Hospital Lucus AugustiLugo, SpainNo longer taking part
- Clinica Universidad de Navarra MadridMadrid, SpainNo longer taking part
- Hospital Clínico San CarlosMadrid, SpainNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpainNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
- Hospital Universitario Ramón y CajalMadrid, SpainNo longer taking part
- Hospital Son LlàtzerPalma de Mallorca, SpainNo longer taking part
- Clinica Universitaria de NavarraPamplona/iruña, SpainNo longer taking part
- Corporacio Sanitaria Parc TauliSabadell, SpainNo longer taking part
- Hospital Universitario Marqués de ValdecillaSantander, SpainNo longer taking part
- Complejo Hospitalario Universitario de Santiago (CHUS)Santiago de Compostela, SpainNo longer taking part
- Hospital Univ. Nuestra Señora de ValmeSeville, SpainNo longer taking part
- Hospital Universitario de TorrejonTorrejón de Ardoz, SpainNo longer taking part
- Hospital Universitari i Politécnic La FeValencia, SpainNo longer taking part
- Hospital Universitario Miguel ServetZaragoza, SpainNo longer taking part
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT04732286
- Record updated
- 8 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
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; Co-infection of HBV and HCV; Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.