Status:
NOT_YET_RECRUITING
The Epidemiology of Patients Treated With ATZ+BEV in Real Life Setting
Lead Sponsor:
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Collaborating Sponsors:
MDX Research
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Brief 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....
Detailed Description
The available information suggests that the ATZ plus BEV is safe and effective as first-line systemic therapy for patients with unresected HCC and advanced HCC. The overall efficacy and safety of the ...
Eligibility Criteria
Inclusion
- 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
- A diagnosis of any other primary cancer prior to the index date
- ATZ plus BEV treatment as part of a clinical trial
- ATZ or BEV given off-label
- Patients with incomplete medical records
- Patients receiving other investigational drugs
- History of hepatic encephalopathy
- Patients with brain metastasis
- HBV and HBC co-infection
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06903663
Start Date
April 1 2025
End Date
December 1 2025
Last Update
April 17 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Fundeni Clinical Institute
Bucharest, Bucharest, Romania, 022328
2
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor"
Cluj-Napoca, Cluj, Romania, 400162
3
Regional Institute of Oncology
Iași, Iaşi, Romania, 700483
4
Oncohelp
Timișoara, Timiș County, Romania, 300239