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
Megadott ok: 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 és Zaragoza, SpanyolországSee the 25 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital General Univ. de AlicanteAlicante, SpanyolországNo longer taking part
- Complejo Hospitalario TorrecardenasAlmería, SpanyolországNo longer taking part
- Hospital Clinic i ProvincialBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital De BasurtoBilbao, SpanyolországNo longer taking part
- Hospital Provincial de CastellónCastellon, SpanyolországNo longer taking part
- Hospital Universitario Reina SofiaCórdoba, SpanyolországNo longer taking part
- Hospital General Universitario de ElcheElche, SpanyolországNo longer taking part
- Complejo Hospitalario de Jaen-Hospital Universitario Medico QuirurgicoJaén, SpanyolországNo longer taking part
- Hospital de Gran Canaria Dr. NegrínLas Palmas de Gran Canaria, SpanyolországNo longer taking part
- Hospital Lucus AugustiLugo, SpanyolországNo longer taking part
- Clinica Universidad de Navarra MadridMadrid, SpanyolországNo longer taking part
- Hospital Clínico San CarlosMadrid, SpanyolországNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Ramón y CajalMadrid, SpanyolországNo longer taking part
- Hospital Son LlàtzerPalma de Mallorca, SpanyolországNo longer taking part
- Clinica Universitaria de NavarraPamplona/iruña, SpanyolországNo longer taking part
- Corporacio Sanitaria Parc TauliSabadell, SpanyolországNo longer taking part
- Hospital Universitario Marqués de ValdecillaSantander, SpanyolországNo longer taking part
- Complejo Hospitalario Universitario de Santiago (CHUS)Santiago de Compostela, SpanyolországNo longer taking part
- Hospital Univ. Nuestra Señora de ValmeSeville, SpanyolországNo longer taking part
- Hospital Universitario de TorrejonTorrejón de Ardoz, SpanyolországNo longer taking part
- Hospital Universitari i Politécnic La FeValencia, SpanyolországNo longer taking part
- Hospital Universitario Miguel ServetZaragoza, SpanyolországNo longer taking part
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT04732286
- Record updated
- 2025. május 8.
- 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.