NCT06903663Not yet recruiting
The Epidemiology of Patients Treated With ATZ+BEV in Real Life Setting
A Multi-Centric, Retrospective, Real-World Study on First-Line Therapy With Atezolizumab Plus Bevacizumab for Advanced or Unresectable Hepatocellular Carcinoma in Romanian Population
Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 12 Feb 2025
- Start date
- Apr 2025
- Primary completion date
- Jul 2025
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06903663
What you commit to
- Study type: Observational
- Planned participants: 100
- From Apr 2025 to the primary completion date, Jul 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A diagnosis of any other primary cancer prior to the index date
- Patients receiving other investigational drugs
Other illness
- History of hepatic encephalopathy
- HBV and HBC co-infection
Other
- ATZ plus BEV treatment as part of a clinical trial
- ATZ or BEV given off-label
- Patients with incomplete medical records
- Patients with brain metastasis
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Regional Institute of Oncology Coordinator of this site? Confirm its status | Iași | Romania | Unknown status |
| Oncohelp Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.