Clinical trial NCT06903663: The Epidemiology of Patients Treated With ATZ+BEV in Real Life Setting
Official title: A Multi-Centric, Retrospective, Real-World Study on First-Line Therapy With Atezolizumab Plus Bevacizumab for Advanced or Unresectable Hepatocellular Carcinoma in Romanian Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Descriptive epidemiology of patients treated with ATZ plus BEV
Pathological features of HCC
Lead sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Sponsor class: OTHER
Collaborators: name: MDX Research
First posted: 2025-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients with a diagnosis of advanced or unresectable HCC undergoing combined therapy with atezolizumab and bevacizumab.

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. 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.

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 combination has been well established in the literature and from the various clinical studies. This combination has since replaced tyrosine kinase inhibitors as the standard for many patients. The combination significantly increases OS (median 19.2 months vs. 13.4 months with sorafenib) and objective response rates (30% vs. 11%), offering better disease control.

The defined primary study outcome is describing the epidemiology of patients treated with ATZ+BEV in real-life setting.

History of the disease, including etiology of liver disease, BCLC stage, MVI, EHS, Child-Pugh Score, ALBI grade, MELD, Betablocker medication, Prior treatment, Resection, Local ablation, TACE/SIRT, BMI, ALT, AST, TBL, Albumin, INR, AFP will be collected and presented.

Data on baseline characteristics, radiological response, treatment patterns and adverse events will be summarized using descriptive statistics. Continuous variables will be presented shown as median and full range, and categorical variables will be reported as frequencies and percentages.

Median duration of therapy was defined as the time from the first administration until the last administration of the drugs. Patients who still received atezolizumab with or without concomitant bevacizumab at data cut-off will be censored.

Patients with at least one staging imaging assessment will be evaluated for radiological response.

Data from patients, who died without radiologically confirmed tumor progression, will be censored at the date of the last radiological assessment or death.

PFS is defined as the time from the date of the first therapy administration until radiological disease progression or death, whatever occurred first. Patients still alive and without radiologically confirmed progression at the date of the last contact or data cut-off will be censored.

OS will be defined as the time from the start of the treatment with atezolizumab and bevacizumab until the date of death.

Survival curves will be calculated with the Kaplan-Meier method and compared by means of the log-rank test.

Safety assessment will consist of monitoring the incidence of all adverse events observed following the treatment with ATZ plus BEV, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5. Safety events will be stratified by type of events, grades, seriousness and will be collected at time points defined in the study flowchart.

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

Primary outcomes:
measure: Description of the epidemiology of patients treated with ATZ+BEV
timeFrame: 36 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) according to viral and non-viral etiology in the selected cohort
timeFrame: 36 months
measure: Overall Survival (OS) for patients treated with the combination therapy
timeFrame: 36 months
measure: Disease Control Rate (DCR)
timeFrame: 36 months
measure: Objective Response Rate (ORR)
timeFrame: 36 months
measure: Duration of Response (DOR)
timeFrame: 36 months
measure: Overall safety of the combined therapy
timeFrame: 36 months
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor"
state: Cluj
city: Timisoara
country: Romania
facility: Oncohelp
state: Timis
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Iasi
country: Romania
facility: Regional Institute of Oncology
Study officials:
affiliation: Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca
name: Adrian Radu Vidra
role: PRINCIPAL_INVESTIGATOR
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