The Epidemiology of Patients Treated With ATZ+BEV in Real Life Setting

Launched by INSTITUTUL REGIONAL DE GASTROENTEROLOGIE & HEPATOLOGIE PROF. DR. OCTAVIAN FODOR · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at patients with hepatocellular carcinoma (HCC), a type of liver cancer, who are receiving a combination treatment called atezolizumab (ATZ) and bevacizumab (BEV) as their first line of therapy. The study aims to gather information about the characteristics of these patients and how they respond to treatment in real-life situations in Romania. Researchers will follow these patients for three years to better understand the effectiveness and safety of this treatment.

To be eligible for the trial, participants must be adults aged 18 or older who have been diagnosed with HCC that cannot be surgically removed and have already started treatment with ATZ and BEV. Additionally, they should have had no prior systemic treatment for HCC and must have specific medical records available for review. Throughout the study, participants can expect regular check-ups to monitor their health and treatment progress. It's important to note that this trial is not currently recruiting participants, and certain criteria, such as having no other primary cancers or specific liver conditions, must be met to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult women and men (≥ 18 years of age) with proven initial diagnosis of HCC with evidence of loco-regional recurrent or advanced disease not amenable to resection.
• • 2. At least one cycle of therapy with ATZ plus BEV.
• • 3. Eligible individuals will be required to have Baseline (pre-index) EGD available
• • 4. No prior systemic therapy for HCC.
• • 5. Evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (At least 1 evaluable CT result over the entire available index and post-index period, excluding the baseline).
• • 6. Patients identified from the patient registry in the hospital with treatment charts between April 1, 2022- December 31, 2024 (index date).
• • 7. Eligible individuals will be required to have data available prior to the index date (pre-index period; baseline characteristics).
• Exclusion Criteria:
• • 1. A diagnosis of any other primary cancer prior to the index date
• • 2. ATZ plus BEV treatment as part of a clinical trial
• • 3. ATZ or BEV given off-label
• • 4. Patients with incomplete medical records
• • 5. Patients receiving other investigational drugs
• • 6. History of hepatic encephalopathy
• • 7. Patients with brain metastasis
• • 8. HBV and HBC co-infection