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.

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).

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma (HCC); Esophageal and/or Gastric Varices
• Intervention / Treatment: Procedure: Esophageal band ligation

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rania M Elkafoury, MD; Phone Number: +201004672358; Email: rania.elkafoury@med.tanta.edu.eg
• Study Contact Backup: Name: Nabila A Elgazzar, MD; Phone Number: 00201288585733; Email: nabilaelgazzar@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbyea
    • Tanta, Gharbyea, Egypt, 31516
      • Recruiting
      • Tanta University Hospitals
      • Contact: Dina H Ziada, MD, head of department; Phone Number: 00201117109990; Email: dina.ziada@med.tanta.edu.eg
      • Principal Investigator: Rania M Elkafoury, MD
      • Sub-Investigator: Madona M Fahmy, MD
      • Sub-Investigator: Nabila A Elgazzar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HCC patients with small non-risky EGVs; 55 patients with small EGVs that had no red signs undergoing variceal band ligation.	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
No Intervention: HCC patients with no or small non-risky EGVs; 55 patients with no or small EGVs that had no red signs. patients will be followed up after 3, 6, 9, 12 months of atezolizumab-bevacizumab therapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Rania M Elkafoury, MD, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; Esophageal varices; atezolizumab-bevacizumab therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Esophageal Diseases; Hypertension, Portal; Carcinoma; Carcinoma, Hepatocellular; Varicose Veins; Esophageal and Gastric Varices
• Other Study ID Numbers: 36264PR1125/3/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No