NCT06961526

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-15
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-05-08
• Last updated: 2025-05-08

Locations

1 site across 1 country: Egypt