Brazilian Reality of Hepatocellular Carcinoma

AstraZeneca300 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Hepatocellular Carcinoma Hepatocellular Carcinoma by BCLC Stage Hepatocellular Carcinoma Stage I Hepatocellular Carcinoma Stage II Hepatocellular Carcinoma Stage III

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (11)

Research Site

Barretos, Brazil

Research Site

Belo Horizonte, Brazil

Research Site

Curitiba, Brazil

Research Site

Natal, Brazil

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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