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NCT Number: NCT06230328

Brazilian Reality of Hepatocellular Carcinoma

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female;
  • Above 18 years old;
  • Hepatocellular carcinoma diagnosis (confirmed by biopsy or imaging);

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Description of clinical condition

    Time frame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Hospital Israelita Albert Einstein

Registry information

Official study title

Brazilian Reality of Hepatocellular Carcinoma - BRA-HEP: Multicenter Retrospective Study (Real World Evidence - RWE)

Acronym: BRA-HEP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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