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

NCT06903663 | Not Yet Recruiting

• 1 other identifier: MANIFEST-HCC-RO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Descriptive epidemiology of patients treated with ATZ plus BEV; Pathological features of HCC

Outcome Measures

Primary Outcomes (1)

• Description of the epidemiology of patients treated with ATZ+BEV

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

  36 months

Secondary Outcomes (6)

• Progression-Free Survival (PFS) according to viral and non-viral etiology in the selected cohort

  36 months

• Overall Survival (OS) for patients treated with the combination therapy

  36 months

• Disease Control Rate (DCR)

  36 months

• Objective Response Rate (ORR)

  36 months

• Duration of Response (DOR)

  36 months

Study Arms (1)

Adult women and men (≥ 18 years of age) with proven initial diagnosis of HCC

Patients with HCC following treatment with ATZ plus BEV identified from the patient registry in the hospital with treatment charts between April 1, 2022- December 31, 2024 (index date).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients with a diagnosis of advanced or unresectable HCC undergoing combined therapy with atezolizumab and bevacizumab.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor: lead
• MDX Research: collaborator

Study Sites (4)

Fundeni Clinical Institute

Bucharest, Bucharest, 022328, Romania

Location

Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor"

Cluj-Napoca, Cluj, 400162, Romania

Location

Regional Institute of Oncology

Iași, Iaşi, 700483, Romania

Location

Oncohelp

Timișoara, Timiș County, 300239, Romania

Location

Related Publications (15)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Adrian Radu Vidra

  Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator Adrian Radu Vidra, MD, Senior Specialist in Medical Oncology

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: April 1, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

RO (4)