Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

  • STATUS
    Recruiting
  • End date
    Jul 9, 2026
  • participants needed
    110
  • sponsor
    Tanta University
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Updated on 9 May 2025
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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).

Details
Condition Esophageal and/or Gastric Varices, Hepatocellular Carcinoma (HCC)
Age 18years or above
Clinical Study IdentifierNCT06961526
SponsorTanta University
Last Modified on9 May 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients with confirmed advanced HCC (Diagnosed by two imaging modalities or liver biopsy) eligible for atezolizumab-bevacizumab therapy
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

Child-Pugh class C patients
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
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