Recruiting

Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

ClinicalTrials.gov IDNCT06961526

PhaseNA

Enrollment110

SponsorTanta University

Age18 Years

SexALL

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Conditions studied

Esophageal and/or Gastric Varices, Hepatocellular Carcinoma (HCC)

About this study

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).

Interventions

Procedure: 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

Primary outcomes

esophagogastric varices progression rate (through study completion, an average of 1 year)
variceal band ligation in small varices without bleeding stigmata (through study completion, an average of 1 year)

Eligibility information

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.

Study locations

Tanta University Hospitals, Tanta, Gharbyea 31516 Egypt

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.