Hepatocellular Carcinoma (HCC)ARTENCT06806579
Atezolizumab-bevacizumab and Other Immunotherapies: Real-life Experience for Treatment of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma (HCC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 24 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 1,000 participants
- Where
- 24 sitesItaly
- Study dates
- 21 Dec 2022to 31 Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Hepatocellular carcinoma not amenable to locoregional procedures
- Candidate to frontline systemic treatment with atezolizumab-bevacizumab or other immunotherapies
Who cannot join
- Concurrent treatment with other antineoplastic agents
- Other active neoplasia
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
Italy24 sites, 24 recruiting
- Recruiting
AUSL Bologna Via Castiglione 15 40136 Bologna BO
Bologna, BO, 40136
Stefania De Lorenzo, 0542662672, stefania.delorenzo@auslbologna.bo.it
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Oncology Unit), Bologna, BO 40136
Bologna, BO, 40136
Giovanni Brandi, +390512143838, giovanni.brandi@unibo.it
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Semiotics Unit)
Bologna, BO, 40136
Paolo Caraceni, +390512142718, paolo.caraceni@unibo.it
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40136
Francesco Tovoli, MD, +390512142214, francesco.tovoli@unibo.it
- Not yet recruiting
I.R.C.C.S. "S. De Bellis", Via Turi, 27, 70013 Castellana Grotte BA
Castellana Grotte, BA, 70013
Francesco Losito, +39 080 499 4111, francesco.losito@gmail.com
- Not yet recruiting
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Garibaldi, Piazza Santa Maria di Gesù, 5, 95123 Catania CT
Catania, CT, 95123
Maurizio Russello, +39 095 759 1111, m.russello@arnasgaribalidi.it
- Recruiting
Ospedale degli Infermi Viale Stradone, 9 48018 Faenza (RA)
Faenza, RA, 48018
Francesco Giuseppe Foschi, 0546 601214, francesco.foschi@auslromagna.it
- Recruiting
AOU Careggi. Largo G. Alessandro Brambilla, 3. 50134 Firenze FI
Florence, FI, 50134
Fabio Marra, +39 055 2758095, fabio.marra@unifi.it
- Recruiting
Ospedali Riuniti. Viale Pinto Luigi, 1, 71122 Foggia FG.
Foggia, FG, 71122
Rodolfo Sacco, +39 0881 731111, saccorodolfo@hotmail.com
- Not yet recruiting
Ospedali Riuniti. Viale Pinto Luigi, 1, 71122 Foggia FG
Foggia, FG, 71122
Gaetano Serviddio, +39 0881 731111, gaetano.serviddio@unifg.it
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. via Francesco Sforza, 28 - 20122 Milano.
Milan, MI, 20122
Massimo Alberto Iavarone, + 39 02 5503.5432, massimo.iavarone@gmail.com
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore, 3, 20162 Milano
Milan, MI, 20162
Chiara Mazzarelli, +39 02 64441, chiara.mazzarelli@ospedaleniguarda.it
- Not yet recruiting
Policlinico di Modena Via del Pozzo, 71, 41125 Modena MO
Modena, Missouri, 41125
Antonio Colecchia, 059 4222111, antonio.colecchia@unimore.it
- Recruiting
P.O. Ospedale del Mare. Via Enrico Russo, 11, 80147 Napoli NA
Naples, 80147
Piera Federico, +39 081 254 1111, piera.federico@yahoo.it
- Not yet recruiting
Azienda Ospedaliero- Universitaria Maggiore della Carità, Padiglione G, L.go Bellini, 28100 Novara NO
Novara, 28100
Cristina Rigamonti, +39 03213731, cristina.rigamonti@uniupo.it
- Recruiting
Istituto Oncologico Veneto. Via Gattamelata, 64, 35128 Padova PD
Padova, PD, 35128
Caterina Soldà, +39 049 821 1111, caterina.solda@iov.veneto.it
- Recruiting
Azienda Ospedaliero- Universitaria Paolo Giaccone. Via Liborio Giuffrè, 5, 90127 Palermo
Palermo, PA, 90127
Giuseppe Cabibbo, +39 091 655 1111, giuseppe.cabibbo@unipa.it
- Recruiting
AOU Pisana. Via Roma 67. 56126 Pisa PI
Pisa, PI, 56126
Masi Gianluca, +39 050 992725, gianluca.masi@unipi.it
- Not yet recruiting
IRCCS Santa Maria Nuova Viale Risorgimento, 80, 42123 Reggio Emilia
Reggio Emilia, RE, 42123
Silvia Fanello, 0522296610, silvia.fanello@ausl.re.it
- Recruiting
Policlinico Gemelli. Largo Agostino Gemelli, 8, 00168 Roma RM
Roma, RM, 00168
Francesca Ponziani, 06 30151, francesca.ponziani@gmail.com
- Recruiting
Humanitas Research Hospital. Via Alessandro Manzoni, 56, 20089 Rozzano MI
Rozzano, MI, 20089
Tiziana Pressiani, + 39 02 82241, tiziana.pressiani@cancercenter.humanitas.it
- Recruiting
Ospedali Riuniti Ancona, Via Conca, 71, 60126 Torrette AN
Torrette, AN, 60126
Gianluca Svegliati-Baroni, +39 071 5961, gsvegliati@gmail.com
- Not yet recruiting
Azienda sanitaria universitaria Friuli Centrale, Piazzale Santa Maria della Misericordia, 15 33100 Udine (UD)
Udine, UD, 33100
Pierluigi Toniutto, +39 0432 5521, pierluigi.toniutto@uniud.it
- Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona. Piazzale Aristide Stefani, 1, 37126 Verona VR
Verona, VR, 37126
+39 045 812 1111, andrea.dalbeni@univr.it
About this study
- 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:
Read more
- 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.
- 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.
Read the detailed description
- 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.
- New Advances in Treatment Options
For many years, sorafenib was the only approved drug for advanced liver cancer when local treatments like surgery were not possible. However, significant advancements have changed the treatment landscape:
- Atezolizumab and Bevacizumab (Immunotherapy Combination): In 2019, a groundbreaking study (ImBRAVE-150, Phase 3) demonstrated that combining atezolizumab (an immunotherapy drug) and bevacizumab (an anti-angiogenic drug) significantly improved disease-free survival (time without cancer worsening) and overall survival compared to sorafenib. This combination was approved in 2019 by the European Medicines Agency (EMA) and later by the Italian Medicines Agency (AIFA) in 2022.
- Durvalumab and Tremelimumab (Dual Immunotherapy):
In February 2024, another combination-durvalumab and tremelimumab-was introduced following the results of the Phase 3 HIMALAYA trial, which also showed improved outcomes compared to sorafenib.
Several other immunotherapy-based combinations, such as camrelizumab-rivoceranib and nivolumab-ipilimumab, are under evaluation and may become available in the future.
- Why Is This Study Important?
- Real-World Effectiveness of Treatments: While clinical trials have shown promising results for atezolizumab-bevacizumab and durvalumab-tremelimumab, real-world data-information gathered from everyday clinical practice-are still limited. In particular, there is a lack of real-world evidence for the new durvalumab-tremelimumab combination. This study aims to fill that gap by collecting and analyzing data from patients treated in daily clinical practice.
- Understanding Treatment Sequences: After completing atezolizumab-bevacizumab or durvalumab-tremelimumab, what is the best next treatment? Currently, the only approved next-line drug is sorafenib, and for third-line treatment in Italy, cabozantinib is the only option. However, there is no clear scientific data on the effectiveness of these treatment sequences. As more therapies become available, it will be critical to identify the best sequence of treatments to extend survival and improve quality of life.
- Identifying Predictors of Response: Some patients respond better to treatment than others. This study seeks to identify clinical and laboratory markers that predict which patients will benefit most from specific therapies. For example, with sorafenib, the development of certain side effects (like skin reactions) was associated with better survival. It remains unclear whether similar markers exist for newer drug combinations. Additionally, the study will examine how factors such as treatment intolerance, patterns of disease progression, and second-line therapies influence survival outcomes.
- What This Study Aims to Achieve
This study will gather and analyze data from patients treated in real-world settings to:
- 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.
- 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)
- Keywords
- atezolizumab, bevacizumab, tremelimumab, durvalumab, immunotherapy, real-life, outcome
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment up to 3 years from the first dose
Secondary outcomes (5)
Progression-free survival
defined as the time between the first administration of atezolizumab-bevacizumab or durvalumab-tremelimumab and radiological progression
Measured: from enrollment up to 3 years from the first dose
Overall survival
defined as the time between the treatment start and the death of the patient, or to the last follow-up evaluation
Measured: from enrollment up to 3 years from the first dose
Objective response rate (ORR)
defined as the percentage of patients who achieve a partial or complete response to the disease on follow-up imaging, according to RECIST 1.1 criteria, out of the total number of patients who undergo at least one radiological assessment.
Measured: from enrollment up to 3 years from the first dose
Rate of Patients Eligible for Second-Line Treatments
defined as the percentage of patients who, after the definitive discontinuation of atezolizumab-bevacizumab or other immunotherapies, have sufficiently good general conditions and liver function to allow the prescription of an additional line of systemic treatment.
Measured: from enrollment up to 3 years from the first dose
Safety monitoring
Incidence of Adverse Events Related to Atezolizumab-Bevacizumab or other immunotherapies
Measured: from enrollment up to 3 years from the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start21 Dec 2022
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Tovoli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806579
- Sponsor's protocol ID
- ARTE
- Acronym
- ARTE
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Privacy regulations
Publications
Stefanini B, Rimassa L, Iavarone M, Cabibbo G, Marra F, Vivaldi C, Dalbeni A, Ponziani FR, Palloni A, Lonardi S, Lani L, Federico P, Svegliati-Baroni G, Pressiani T, Ielasi L, Mazzarelli C, De Lorenzo S, Sacco R, Bruccoleri M, Celsa C, Mastro A, Masi G, Auriemma A, Stella L, Toniutto P, Villani R, Deiana C, Ascari S, Marseglia M, Granito A, Piscaglia F, Tovoli F; ARTE Study Group. Stratifying Cardiovascular Risk in Patients With HCC Receiving Atezolizumab/Bevacizumab: A Comparison of ESC and CARDIOSOR Scores. Liver Int. 2026 Nov;46(11):e70909. doi: 10.1111/liv.70909.
PubMed 42839680
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atezolizumab-bevacizumab and Other Immunotherapies: Real-life Experience for Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06806579
- Acronym / sponsor ID
- ARTE / ARTE
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- atezolizumab, bevacizumab, tremelimumab, durvalumab, immunotherapy, real-life, outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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.
- 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.
Detailed description
- 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.
- New Advances in Treatment Options
For many years, sorafenib was the only approved drug for advanced liver cancer when local treatments like surgery were not possible. However, significant advancements have changed the treatment landscape:
- Atezolizumab and Bevacizumab (Immunotherapy Combination): In 2019, a groundbreaking study (ImBRAVE-150, Phase 3) demonstrated that combining atezolizumab (an immunotherapy drug) and bevacizumab (an anti-angiogenic drug) significantly improved disease-free survival (time without cancer worsening) and overall survival compared to sorafenib. This combination was approved in 2019 by the European Medicines Agency (EMA) and later by the Italian Medicines Agency (AIFA) in 2022.
- Durvalumab and Tremelimumab (Dual Immunotherapy):
In February 2024, another combination-durvalumab and tremelimumab-was introduced following the results of the Phase 3 HIMALAYA trial, which also showed improved outcomes compared to sorafenib.
Several other immunotherapy-based combinations, such as camrelizumab-rivoceranib and nivolumab-ipilimumab, are under evaluation and may become available in the future.
- Why Is This Study Important?
- Real-World Effectiveness of Treatments: While clinical trials have shown promising results for atezolizumab-bevacizumab and durvalumab-tremelimumab, real-world data-information gathered from everyday clinical practice-are still limited. In particular, there is a lack of real-world evidence for the new durvalumab-tremelimumab combination. This study aims to fill that gap by collecting and analyzing data from patients treated in daily clinical practice.
- Understanding Treatment Sequences: After completing atezolizumab-bevacizumab or durvalumab-tremelimumab, what is the best next treatment? Currently, the only approved next-line drug is sorafenib, and for third-line treatment in Italy, cabozantinib is the only option. However, there is no clear scientific data on the effectiveness of these treatment sequences. As more therapies become available, it will be critical to identify the best sequence of treatments to extend survival and improve quality of life.
- Identifying Predictors of Response: Some patients respond better to treatment than others. This study seeks to identify clinical and laboratory markers that predict which patients will benefit most from specific therapies. For example, with sorafenib, the development of certain side effects (like skin reactions) was associated with better survival. It remains unclear whether similar markers exist for newer drug combinations. Additionally, the study will examine how factors such as treatment intolerance, patterns of disease progression, and second-line therapies influence survival outcomes.
- What This Study Aims to Achieve
This study will gather and analyze data from patients treated in real-world settings to:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Hepatocellular carcinoma not amenable to locoregional procedures
- Candidate to frontline systemic treatment with atezolizumab-bevacizumab or other immunotherapies
Key exclusion criteria (2 listed)
- Concurrent treatment with other antineoplastic agents
- Other active neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate toxicity as first-line therapy
Time frame: 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
5 secondary outcomes
Progression-free survival
Time frame: from enrollment up to 3 years from the first dose
Overall survival
Time frame: from enrollment up to 3 years from the first dose
Objective response rate (ORR)
Time frame: from enrollment up to 3 years from the first dose
Rate of Patients Eligible for Second-Line Treatments
Time frame: from enrollment up to 3 years from the first dose
Safety monitoring
Time frame: from enrollment up to 3 years from the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Derived from this study: PubMed 42839680Stefanini B, Rimassa L, Iavarone M, Cabibbo G, Marra F, Vivaldi C, Dalbeni A, Ponziani FR, Palloni A, Lonardi S, Lani L, Federico P, Svegliati-Baroni G, Pressiani T, Ielasi L, Mazzarelli C, De Lorenzo S, Sacco R, Bruccoleri M, Celsa C, Mastro A, Masi G, Auriemma A, Stella L, Toniutto P, Villani R, Deiana C, Ascari S, Marseglia M, Granito A, Piscaglia F, Tovoli F; ARTE Study Group. Stratifying Cardiovascular Risk in Patients With HCC Receiving Atezolizumab/Bevacizumab: A Comparison of ESC and CARDIOSOR Scores. Liver Int. 2026 Nov;46(11):e70909. doi: 10.1111/liv.70909.
- link to full text paper (open access)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Privacy regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Tovoli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Tovoli, MD (+390512142214, francesco.tovoli@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate toxicity as first-line therapy (time frame: from enrollment up to 3 years from the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.