Brazilian Reality of Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma Stage III; Hepatocellular Carcinoma Stage I; Hepatocellular Carcinoma by BCLC Stage; Hepatocellular Carcinoma Stage II

• Registration Number: NCT06230328
• Lead Sponsor: AstraZeneca

Brief 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 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 Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-30
• Study Start: 2024-04-15
• Status Verified: 2024-11
• Primary Completion: 2024-11-14
• Study Completion: 2024-11-14
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiological profile and pathological staging	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 Outcome Measures

Name	Time	Method
Description of clinical condition	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.

Trial Locations

Locations (1)

Research Site; 🇧🇷 Vitoria, Brazil