The Epidemiology of Patients Treated With ATZ+BEV in Real Life Setting (NCT06903663) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Epidemiology of Patients Treated With ATZ+BEV in Real Life Setting
Romania100 participantsStarted 2025-04
Plain-language summary
Hepatocellular carcinoma (HCC) is the sixth most prevalent cancer and the third most frequent cause of cancer-related death globally.
This retrospective, multicentric study will be coordinated by Dr. Adrian Radu Vidra (Lead Investigator) from Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca (Coordinating Site) to further investigate the clinical and demographic profile of patients receiving first-line treatment with atezolizumab and bevacizumab in the real-world setting of clinical practice from Romania.
Participants already taking the combination therapy as part of their regular medical care for HCC will be followed during 3 years.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. At least one cycle of therapy with ATZ plus BEV.
✓. Eligible individuals will be required to have Baseline (pre-index) EGD available
✓. No prior systemic therapy for HCC.
✓. 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).
✓. Patients identified from the patient registry in the hospital with treatment charts between April 1, 2022- December 31, 2024 (index date).
✓. Eligible individuals will be required to have data available prior to the index date (pre-index period; baseline characteristics).
Exclusion criteria
✕. A diagnosis of any other primary cancer prior to the index date
What they're measuring
1
Description of the epidemiology of patients treated with ATZ+BEV
Timeframe: 36 months
Trial details
NCT IDNCT06903663
SponsorInstitutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor