Actively Recruiting
Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
Led by Tanta University · Updated on 2025-05-08
110
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective cohort study is to evaluate the progression of esophagogastric varices in patients treated with atezolizumab-bevacizumab. Assess the efficacy of primary prophylaxis of small esophageal varices with no risky signs and shortening endoscopic follow-up time intervals to reduce the risk of variceal hemorrhage. 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).
CONDITIONS
Official Title
Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed advanced hepatocellular carcinoma diagnosed by two imaging methods or liver biopsy
- Patients eligible for atezolizumab-bevacizumab therapy
- Patients with preserved liver function (compensated Child-Pugh A if cirrhosis is present)
- Patients with performance status 2 or less at staging work-up
- Patients with no or grade 1 non-risky esophageal varices on pretreatment endoscopy
You will not qualify if you...
- Patients with Child-Pugh class C liver function
- Patients with performance status greater than 2 at staging work-up
- Patients with vascular disorders or arterial hypertension
- Patients with severe autoimmune disorders
- Patients lost to follow-up
- Pregnant or breastfeeding women
- Patients unwilling to participate in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tanta University Hospitals
Tanta, Gharbyea, Egypt, 31516
Actively Recruiting
Research Team
R
Rania M Elkafoury, MD
CONTACT
N
Nabila A Elgazzar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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