Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

Not Applicable

Recruiting

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

• Registration Number: NCT06961526
• Lead Sponsor: Tanta University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
esophagogastric varices progression rate	through study completion, an average of 1 year	evaluating esophagogastric varices progression rate at 3, 5, 9, and 12 months of starting atezolizumab-bevacizumab therapy.
variceal band ligation in small varices without bleeding stigmata	through study completion, an average of 1 year	Evaluating the effect of variceal band ligation in small varices without bleeding stigmata in reducing the variceal bleeding rate.

Secondary Outcome Measures

Name	Time	Method
shortening the endoscopic follow-up intervals	through study completion, an average of 1 year	Evaluating the effect of shortening the endoscopic follow-up intervals to reduce the variceal bleeding rate in patients treated with atezolizumab-bevacizumab therapy.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbyea, Egypt