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

Not yet recruiting

• Conditions: Hepatocellular Carcinoma (HCC)

• Registration Number: NCT06903663
• Lead Sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

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.

Study Timeline

• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the epidemiology of patients treated with ATZ+BEV	36 months	The defined primary study outcome is describing the epidemiology of patients treated with ATZ+BEV in real life setting.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) according to viral and non-viral etiology in the selected cohort	36 months	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.
Overall safety of the combined therapy	36 months	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.
Overall Survival (OS) for patients treated with the combination therapy	36 months	OS will be defined as the elapsed time from onset of the treatment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will be performed at 12, 24, 30, 36 months (3.0 years).
Disease Control Rate (DCR)	36 months	DCR will be calculated per modified Response Evaluation Criteria in Solid Tumors (mRECIST) V1.1 criterion, as the proportion of patients with best overall response to protocol therapy of complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 12 weeks.
Objective Response Rate (ORR)	36 months	ORR will be defined as the proportion of the patients with a confirmed CR or PR, as per mRECIST V1.1 criterion.
Duration of Response (DOR)	36 months	DOR will be defined as the elapsed time from documented tumor response to documented disease progression or death from any cause.

Trial Locations

Locations (4)

Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor"; 🇷🇴 Cluj-Napoca, Cluj, Romania

Oncohelp; 🇷🇴 Timisoara, Timis, Romania

Fundeni Clinical Institute; 🇷🇴 Bucharest, Romania

Regional Institute of Oncology; 🇷🇴 Iasi, Romania