Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
NCT ID: NCT06961526
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2025-02-15
2026-07-31
Brief Summary
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Researchers will assess the progression of esophageal varices (EVs) with no bleeding stigmata in patients treated with atezolizumab-bevacizumab therapy at 3, 6, 9, and 12 months with endoscopic examination. Evaluate the effect of shortening the endoscopic follow-up intervals to reduce the risk of variceal bleeding in patients treated with atezolizumab-bevacizumab therapy. Researchers will also assess the efficacy of variceal band ligation in small varices without bleeding stigmata before starting atezolizumab-bevacizumab therapy to reduce the progression of EVs.
Participants will undergo history-taking, clinical examination, laboratory investigations, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), abdominal ultrasonography, and upper endoscopy (within 6 months before beginning of systemic therapy and followed up after 3, 6, 9, and 12 months).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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HCC patients with small non-risky EGVs
55 patients with small EGVs that had no red signs undergoing variceal band ligation.
Esophageal band ligation
upper endoscopy will be performed within 6 months before starting atezolizumab-bevacizumab therapy in HCC patients. Esophageal band ligation for small non-risky varices before starting atezolizumab-bevacizumab therapy. Endoscopy will be repeated 3, 5, 9, 12 months after atezolizumab-bevacizumab therapy
HCC patients with no or small non-risky EGVs
55 patients with no or small EGVs that had no red signs. patients will be followed up after 3, 6, 9, 12 months of atezolizumab-bevacizumab therapy.
No interventions assigned to this group
Interventions
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Esophageal band ligation
upper endoscopy will be performed within 6 months before starting atezolizumab-bevacizumab therapy in HCC patients. Esophageal band ligation for small non-risky varices before starting atezolizumab-bevacizumab therapy. Endoscopy will be repeated 3, 5, 9, 12 months after atezolizumab-bevacizumab therapy
Eligibility Criteria
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Inclusion Criteria
* Patients with preserved liver function (compensated Child-Pugh A if there is underlying cirrhosis).
* Patients with performance status ≤2 at staging work-up.
* Patients with no or grade 1 non-risky esophageal varices on pretreatment endoscopic examination.
Exclusion Criteria
* Patients with performance status \>2 at staging work-up.
* Vascular disorders and arterial hypertension.
* Severe autoimmune disorders.
* Patients who lost follow-up.
* Pregnant or breastfeeding women.
* Unwilling to participate in our study.
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Principal Investigators
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Rania M Elkafoury, MD
Role: PRINCIPAL_INVESTIGATOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Locations
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Tanta University Hospitals
Tanta, Gharbyea, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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36264PR1125/3/25
Identifier Type: -
Identifier Source: org_study_id
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