Brazilian Reality of Hepatocellular Carcinoma (BRA-HEP)

AstraZeneca

Status

Completed

Conditions

Hepatocellular Carcinoma by BCLC Stage

Hepatocellular Carcinoma Stage I

Hepatocellular Carcinoma Stage II

Hepatocellular Carcinoma

Hepatocellular Carcinoma Stage III

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06230328

BRA-HEP

D133HR00024

Details and patient eligibility

About

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).

Full 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).

Enrollment

300 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.