Observational Recruiting
NCT06806579 on ClinicalTrials.gov
Atezolizumab-bevacizumab and Other Immunotherapies: Real-life Experience for Treatment of Hepatocellular Carcinoma
- Sponsor: Policlinico S.Orsola-Malpighi
- Enrollment: 1000 (Estimated)
- Study start: 2022-12-21 (Actual)
- Primary completion: 2030-10-31 (Estimated)
- Study completion: 2031-10-31 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief Summary
- Background Hepatocellular carcinoma (HCC), is the fifth most common cancer worldwide and the third leading cause of cancer-related death. In most cases (about 80%), HCC develops in a cirrhotic liver - a condition where the liver has been damaged over time, leading to scarring. This makes treatment more challenging.
This study will gather and analyze data from patients treated in real-world settings to:
1. Understand the effectiveness and safety of new treatment combinations (e.g., atezolizumab-bevacizumab and durvalumab-tremelimumab).
Identify the best treatment sequences for patients with advanced liver cancer.
2. Discover clinical and laboratory markers that predict treatment responses, helping personalize care and optimize outcomes.
By addressing these questions, this study will provide valuable information to healthcare providers and guide future treatment decisions for patients with liver cancer.
Conditions
- Hepatocellular Carcinoma (HCC)
Primary Outcome Measures
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Evaluate toxicity as first-line therapy
(from enrollment up to 3 years from the first dose)
To evaluate toxicity of therapeutic sequences in which atezolizumab-bevacizumab or other immunothrapies were administered as first-line therapy within the standard care pathway for patients with hepatocellular carcinoma. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Countries
Italy
Locations and Investigators
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Ospedali Riuniti Ancona, Via Conca, 71, 60126 Torrette AN, Torrette, Italy (Recruiting)
- Gianluca Svegliati-Baroni
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I.R.C.C.S. "S. De Bellis", Via Turi, 27, 70013 Castellana Grotte BA, Castellana Grotte, Italy (Not yet recruiting)
- Francesco Losito
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AUSL Bologna Via Castiglione 15 40136 Bologna BO, Bologna, Italy (Recruiting)
- Stefania De Lorenzo
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IRCCS Azienda Ospedaliero-Universitaria di Bologna (Oncology Unit), Bologna, BO 40136, Bologna, Italy (Recruiting)
- Giovanni Brandi
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IRCCS Azienda Ospedaliero-Universitaria di Bologna (Semiotics Unit), Bologna, Italy (Recruiting)
- Paolo Caraceni
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IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (Recruiting)
- Francesco Tovoli, MD
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Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Garibaldi, Piazza Santa Maria di Gesù, 5, 95123 Catania CT, Catania, Italy (Not yet recruiting)
- Maurizio Russello
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Ospedali Riuniti. Viale Pinto Luigi, 1, 71122 Foggia FG., Foggia, Italy (Recruiting)
- Rodolfo Sacco
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Ospedali Riuniti. Viale Pinto Luigi, 1, 71122 Foggia FG, Foggia, Italy (Not yet recruiting)
- Gaetano Serviddio
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AOU Careggi. Largo G. Alessandro Brambilla, 3. 50134 Firenze FI, Firenze, Italy (Recruiting)
- Fabio Marra
- Policlinico di Modena Via del Pozzo, 71, 41125 Modena MO, Modena, Italy (Not yet recruiting)
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. via Francesco Sforza, 28 - 20122 Milano., Milano, Italy (Recruiting)
- Massimo Alberto Iavarone
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ASST Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore, 3, 20162 Milano, Milano, Italy (Not yet recruiting)
- Chiara Mazzarelli
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Humanitas Research Hospital. Via Alessandro Manzoni, 56, 20089 Rozzano MI, Rozzano, Italy (Recruiting)
- Tiziana Pressiani
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Azienda Ospedaliero- Universitaria Paolo Giaccone. Via Liborio Giuffrè, 5, 90127 Palermo, Palermo, Italy (Recruiting)
- Giuseppe Cabibbo
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Istituto Oncologico Veneto. Via Gattamelata, 64, 35128 Padova PD, Padova, Italy (Recruiting)
- Caterina SoldÃ
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AOU Pisana. Via Roma 67. 56126 Pisa PI, Pisa, Italy (Recruiting)
- Masi Gianluca
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Ospedale degli Infermi Viale Stradone, 9 48018 Faenza (RA), Faenza, Italy (Recruiting)
- Francesco Giuseppe Foschi
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IRCCS Santa Maria Nuova Viale Risorgimento, 80, 42123 Reggio Emilia, Reggio Emilia, Italy (Not yet recruiting)
- Silvia Fanello
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Policlinico Gemelli. Largo Agostino Gemelli, 8, 00168 Roma RM, Roma, Italy (Recruiting)
- Francesca Ponziani
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Azienda sanitaria universitaria Friuli Centrale, Piazzale Santa Maria della Misericordia, 15 33100 Udine (UD), Udine, Italy (Not yet recruiting)
- Pierluigi Toniutto
- Azienda Ospedaliera Universitaria Integrata di Verona. Piazzale Aristide Stefani, 1, 37126 Verona VR, Verona, Italy (Recruiting)
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P.O. Ospedale del Mare. Via Enrico Russo, 11, 80147 Napoli NA, Napoli, Italy (Recruiting)
- Piera Federico
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Azienda Ospedaliero- Universitaria Maggiore della Carità , Padiglione G, L.go Bellini, 28100 Novara NO, Novara, Italy (Not yet recruiting)
- Cristina Rigamonti
Study Officials
- Francesco Tovoli, MD (Principal Investigator) — IRCCS Azienda Ospedaliero-Universitaria di Bologna