Atezolizumab-bevacizumab and Other Immunotherapies: Real-life Experience for Treatment of Hepatocellular Carcinoma
ARTE
1 other identifier
observational
1,000
1 country
24
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).
- 2.Discover clinical and laboratory markers that predict treatment responses, helping personalize care and optimize outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2022
CompletedFirst Submitted
Initial submission to the registry
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2031
February 4, 2025
December 1, 2024
7.9 years
January 10, 2025
January 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate toxicity as first-line therapy
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
from enrollment up to 3 years from the first dose
Secondary Outcomes (5)
Progression-free survival
from enrollment up to 3 years from the first dose
Overall survival
from enrollment up to 3 years from the first dose
Objective response rate (ORR)
from enrollment up to 3 years from the first dose
Rate of Patients Eligible for Second-Line Treatments
from enrollment up to 3 years from the first dose
Safety monitoring
from enrollment up to 3 years from the first dose
Eligibility Criteria
Data will be collected from patients with hepatocellular carcinoma (HCC) who are candidates for treatment with atezolizumab-bevacizumab or durvalumab-tremelimumab. Patients will be evaluated in outpatient clinics or inpatient departments of the participating centers as part of the standard care pathway for HCC patients. Data will be collected at the patient's first evaluation and during subsequent assessments (approximately every 3-4 weeks), as per the routine care process for HCC patients receiving pharmacological treatments. The follow-up observation for each patient will continue as part of the standard care pathway.
You may qualify if:
- Hepatocellular carcinoma not amenable to locoregional procedures
- Candidate to frontline systemic treatment with atezolizumab-bevacizumab or other immunotherapies
You may not qualify if:
- Concurrent treatment with other antineoplastic agents
- Other active neoplasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Ospedali Riuniti Ancona, Via Conca, 71, 60126 Torrette AN
Torrette, AN, 60126, Italy
I.R.C.C.S. "S. De Bellis", Via Turi, 27, 70013 Castellana Grotte BA
Castellana Grotte, BA, 70013, Italy
AUSL Bologna Via Castiglione 15 40136 Bologna BO
Bologna, BO, 40136, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Oncology Unit), Bologna, BO 40136
Bologna, BO, 40136, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Semiotics Unit)
Bologna, BO, 40136, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40136, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Garibaldi, Piazza Santa Maria di Gesù, 5, 95123 Catania CT
Catania, CT, 95123, Italy
Ospedali Riuniti. Viale Pinto Luigi, 1, 71122 Foggia FG.
Foggia, FG, 71122, Italy
Ospedali Riuniti. Viale Pinto Luigi, 1, 71122 Foggia FG
Foggia, FG, 71122, Italy
AOU Careggi. Largo G. Alessandro Brambilla, 3. 50134 Firenze FI
Florence, FI, 50134, Italy
Policlinico di Modena Via del Pozzo, 71, 41125 Modena MO
Modena, Missouri, 41125, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. via Francesco Sforza, 28 - 20122 Milano.
Milan, MI, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore, 3, 20162 Milano
Milan, MI, 20162, Italy
Humanitas Research Hospital. Via Alessandro Manzoni, 56, 20089 Rozzano MI
Rozzano, MI, 20089, Italy
Azienda Ospedaliero- Universitaria Paolo Giaccone. Via Liborio Giuffrè, 5, 90127 Palermo
Palermo, PA, 90127, Italy
Istituto Oncologico Veneto. Via Gattamelata, 64, 35128 Padova PD
Padua, PD, 35128, Italy
AOU Pisana. Via Roma 67. 56126 Pisa PI
Pisa, PI, 56126, Italy
Ospedale degli Infermi Viale Stradone, 9 48018 Faenza (RA)
Faenza, RA, 48018, Italy
IRCCS Santa Maria Nuova Viale Risorgimento, 80, 42123 Reggio Emilia
Reggio Emilia, RE, 42123, Italy
Policlinico Gemelli. Largo Agostino Gemelli, 8, 00168 Roma RM
Roma, RM, 00168, Italy
Azienda sanitaria universitaria Friuli Centrale, Piazzale Santa Maria della Misericordia, 15 33100 Udine (UD)
Udine, UD, 33100, Italy
Azienda Ospedaliera Universitaria Integrata di Verona. Piazzale Aristide Stefani, 1, 37126 Verona VR
Verona, VR, 37126, Italy
P.O. Ospedale del Mare. Via Enrico Russo, 11, 80147 Napoli NA
Napoli, 80147, Italy
Azienda Ospedaliero- Universitaria Maggiore della Carità, Padiglione G, L.go Bellini, 28100 Novara NO
Novara, 28100, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Tovoli, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2025
First Posted
February 4, 2025
Study Start
December 21, 2022
Primary Completion (Estimated)
October 31, 2030
Study Completion (Estimated)
October 31, 2031
Last Updated
February 4, 2025
Record last verified: 2024-12