Hepatocellular CarcinomaBRA-HEPNCT06230328
Brazilian Reality of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma by BCLC Stage, run by AstraZeneca at 11 sites in Brazil.
Trial summary
National, multicenter, retrospective, non-randomized observational study (Real World Evidence-RWE) with the purpose of analyzing the epidemiological profile of Hepatocellular Carcinomas (BCLC A, B or C), clinical management, progression profile and overall survival of castrated patients treated in national oncology… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Carcinoma by BCLC Stage, Hepatocellular Carcinoma Stage I
- How many people
- 300 participants
- Where
- 11 sitesBrazil
- Study dates
- 15 Apr 2024to 14 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a hepatocellular carcinoma diagnosis (early and intermediate), meeting the eligibility criteria, who have had a 1st time visit to the study sites between 2017 and 2022, and with at least 2 visits with accessible information in the medical record will be included.
Who may be able to join
- Male and female;
- Above 18 years old;
- Hepatocellular carcinoma diagnosis (confirmed by biopsy or imaging);
Who cannot join
- Fibrollamelar carcinoma, hepatoblastoma, intrahepatic cholangiocarcinoma, neuroendocrine tumors or other less common types of liver tumors;
- Patients with incomplete staging data;
- Patients with only 1 visit to the participating site healthcare service, with loss to follow-up prior to the second visit to the participating site healthcare service;
- Previous treatment for hepatocellular carcinoma in another institution;
- Treatment with investigational drugs in a clinical trial.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Research Site
Barretos
Research Site
Belo Horizonte
Research Site
Curitiba
Research Site
Natal
Research Site
Porto Alegre
Research Site
Recife
Research Site
Rio de Janeiro
Research Site
Salvador
Research Site
São Bernardo do Campo
Research Site
São Paulo
Research Site
Vitória
About this study
Official title: Brazilian Reality of Hepatocellular Carcinoma - BRA-HEP: Multicenter Retrospective Study (Real World Evidence - RWE)
National, multicenter, retrospective, non-randomized observational study (Real World Evidence-RWE) with the purpose of analyzing the epidemiological profile of Hepatocellular Carcinomas (BCLC A, B or C), clinical management, progression profile and overall survival of castrated patients treated in national oncology care reference centers, within the last 6 years (between 2017 to 2022).
Read the detailed description
Hepatocellular carcinoma is the third leading cause of cancer-related deaths worldwide. Prognosis strongly depends of the underlying liver disease, tumor-specific characteristics such as tumor load, extrahepatic spread and portal vein branch thrombosis, as well as access to treatments. The Brazilian reality of hepatocellular tumor clinical presentation varies widely and the management profile, treatments adopted and response rates are little described. Taking into consideration the heterogeneity of health services in reference centers in Brazil, knowing the epidemiology profile and treatment of these tumors is of paramount importance to improve care for patients, deepen the knowledge in these diseases and foster for the generation of new regional researches. The primary objective of this study is to determine and describe the epidemiological profile of hepatocellular carcinoma BCLC (Barcelona Algorithm of Liver Cancer) stages 0, A, B and C of patients followed in Brazilian reference oncology centers, within the last 6 years (between 2017 to 2022). The secondary objective is to describe the treatment and endpoints patterns of 2 disease cohorts: early disease (BCLC 0, A and B) and advanced disease (BCLC C).
- Conditions
- Hepatocellular Carcinoma, Hepatocellular Carcinoma by BCLC Stage, Hepatocellular Carcinoma Stage I, Hepatocellular Carcinoma Stage II, Hepatocellular Carcinoma Stage III
- Keywords
- Hepatocellular carcinoma; RWE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with early tumors at diagnosis (BCLC 0, A or B) | |
| Cohort 2 | Pacientes com tumores avançados ao diagnóstico (BCLC C ou D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological profile and pathological staging
Identify the epidemiological profile and pathological staging of patients diagnosed with hepatocellular carcinoma treated at participating centers. Describe the treatments adopted and the response to the progression or non-progression of the disease.
Measured: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Secondary outcomes (1)
Description of clinical condition
Number of injuries, presence of extrahepatic disease, portal vein thrombosis and history of upper gastrointestinal bleeding, use of local therapies, type of local therapies, use of systemic therapies, progression, and conversion rate for resection or transplantation.
Measured: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start15 Apr 2024
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein
- Responsible party
- Sponsor
- Investigators
- Diogo Bugano, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230328
- Sponsor's protocol ID
- D133HR00024
- Other IDs
- BRA-HEP
- Acronym
- BRA-HEP
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Diniz Gomes Bugano D, Batista EC, Fernandes I, Sanches Faria Pinto G, Fiorin de Vasconcellos V, Cembranelli Teixeira R, Cunha Sousa Oliveira S, Kruschewsky Coutinho Araujo A, Lopes Ponte de Souza A, Cordeiro Felismino T, Fernando Weschenfelder R, Pedro Guedes Camandaroba M, Pereira M, Miranda Duarte F, Lopes da Silva M, Andrade de Souza V, Gabriely Costa Oliveira I, Dos Santos Sampaio B, Regina Lamas Assis S, Prado Dos Santos G, Monfardini F, Duarte Fagundes Moia D, Soares R, Vicente Rizzo L, Reis Alvares da Silva M. Real-World Epidemiology, Treatment Patterns, and Outcomes of Hepatocellular Carcinoma in Brazil: A Multicenter Retrospective Study. JCO Glob Oncol. 2026 Jun;12(6):e2500526. doi: 10.1200/GO-25-00526. Epub 2026 Jun 24.
PubMed 42341247
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Reality of Hepatocellular Carcinoma - BRA-HEP: Multicenter Retrospective Study (Real World Evidence - RWE)
- ClinicalTrials.gov ID
- NCT06230328
- Acronym / sponsor ID
- BRA-HEP / D133HR00024
- Conditions
- Hepatocellular Carcinoma, Hepatocellular Carcinoma by BCLC Stage, Hepatocellular Carcinoma Stage I, Hepatocellular Carcinoma Stage II, Hepatocellular Carcinoma Stage III
- Keywords
- Hepatocellular carcinoma; RWE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 30 Jan 2024 (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.
National, multicenter, retrospective, non-randomized observational study (Real World Evidence-RWE) with the purpose of analyzing the epidemiological profile of Hepatocellular Carcinomas (BCLC A, B or C), clinical management, progression profile and overall survival of castrated patients treated in national oncology care reference centers, within the last 6 years (between 2017 to 2022).
Detailed description
Hepatocellular carcinoma is the third leading cause of cancer-related deaths worldwide. Prognosis strongly depends of the underlying liver disease, tumor-specific characteristics such as tumor load, extrahepatic spread and portal vein branch thrombosis, as well as access to treatments. The Brazilian reality of hepatocellular tumor clinical presentation varies widely and the management profile, treatments adopted and response rates are little described. Taking into consideration the heterogeneity of health services in reference centers in Brazil, knowing the epidemiology profile and treatment of these tumors is of paramount importance to improve care for patients, deepen the knowledge in these diseases and foster for the generation of new regional researches. The primary objective of this study is to determine and describe the epidemiological profile of hepatocellular carcinoma BCLC (Barcelona Algorithm of Liver Cancer) stages 0, A, B and C of patients followed in Brazilian reference oncology centers, within the last 6 years (between 2017 to 2022). The secondary objective is to describe the treatment and endpoints patterns of 2 disease cohorts: early disease (BCLC 0, A and B) and advanced disease (BCLC C).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients with early tumors at diagnosis (BCLC 0, A or B) |
| Cohort 2 | – | –Pacientes com tumores avançados ao diagnóstico (BCLC C ou D) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a hepatocellular carcinoma diagnosis (early and intermediate), meeting the eligibility criteria, who have had a 1st time visit to the study sites between 2017 and 2022, and with at least 2 visits with accessible information in the medical record will be included.
Key inclusion criteria (3 listed)
- Male and female;
- Above 18 years old;
- Hepatocellular carcinoma diagnosis (confirmed by biopsy or imaging);
Key exclusion criteria (5 listed)
- Fibrollamelar carcinoma, hepatoblastoma, intrahepatic cholangiocarcinoma, neuroendocrine tumors or other less common types of liver tumors;
- Patients with incomplete staging data;
- Patients with only 1 visit to the participating site healthcare service, with loss to follow-up prior to the second visit to the participating site healthcare service;
- Previous treatment for hepatocellular carcinoma in another institution;
- Treatment with investigational drugs in a clinical trial.
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
Epidemiological profile and pathological staging
Time frame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Identify the epidemiological profile and pathological staging of patients diagnosed with hepatocellular carcinoma treated at participating centers. Describe the treatments adopted and the response to the progression or non-progression of the disease.
1 secondary outcome
Description of clinical condition
Time frame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 42341247Diniz Gomes Bugano D, Batista EC, Fernandes I, Sanches Faria Pinto G, Fiorin de Vasconcellos V, Cembranelli Teixeira R, Cunha Sousa Oliveira S, Kruschewsky Coutinho Araujo A, Lopes Ponte de Souza A, Cordeiro Felismino T, Fernando Weschenfelder R, Pedro Guedes Camandaroba M, Pereira M, Miranda Duarte F, Lopes da Silva M, Andrade de Souza V, Gabriely Costa Oliveira I, Dos Santos Sampaio B, Regina Lamas Assis S, Prado Dos Santos G, Monfardini F, Duarte Fagundes Moia D, Soares R, Vicente Rizzo L, Reis Alvares da Silva M. Real-World Epidemiology, Treatment Patterns, and Outcomes of Hepatocellular Carcinoma in Brazil: A Multicenter Retrospective Study. JCO Glob Oncol. 2026 Jun;12(6):e2500526. doi: 10.1200/GO-25-00526. Epub 2026 Jun 24.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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. This study is not recruiting at the moment.
Diogo Bugano principal investigator
Hospital Israelita Albert Einstein
11 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 and Hepatocellular Carcinoma by BCLC Stage, run by AstraZeneca at 11 sites in Brazil.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological profile and pathological staging (time frame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)). 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 NCT06230328, 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 29 Sep 2025.