RecruitingNot ApplicableNCT06961526

Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

Primary Prophylaxis of Esophageal Varices in Patients Treated With Atezolizumab and Bevacizumab for Advanced Hepatocellular Carcinoma.


Sponsor

Tanta University

Enrollment

110 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a preventive treatment for esophageal varices (enlarged veins in the food pipe that can bleed dangerously) improves outcomes in patients with advanced liver cancer (HCC) who are starting a specific immunotherapy combination called atezolizumab plus bevacizumab. This is an observational study. **You may be eligible if...** - You have been diagnosed with advanced liver cancer (HCC) confirmed by imaging or biopsy - Your liver is still functioning reasonably well (Child-Pugh A) - You are well enough to carry out daily activities (performance status 2 or better) - You have no or only small, low-risk varices seen on an endoscopy before treatment - You are eligible for atezolizumab-bevacizumab therapy **You may NOT be eligible if...** - Your liver disease is very advanced (Child-Pugh C) - You have significant vascular problems or uncontrolled high blood pressure - You have a severe autoimmune disorder - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEsophageal 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


Locations(1)

Tanta University Hospitals

Tanta, Gharbyea, Egypt

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NCT06961526


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