Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

NCT06961526 | Recruiting

• 1 other identifier: 36264PR1125/3/25
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Esophageal varices; hepatocellular carcinoma; atezolizumab-bevacizumab therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• shortening the endoscopic follow-up intervals

  through study completion, an average of 1 year

Study Arms (2)

HCC patients with small non-risky EGVs

ACTIVE COMPARATOR

55 patients with small EGVs that had no red signs undergoing variceal band ligation.

Procedure: Esophageal band ligation

HCC patients with no or small non-risky EGVs

NO INTERVENTION

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.

Interventions

Esophageal band ligation PROCEDURE

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

HCC patients with small non-risky EGVs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Rania M Elkafoury, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Nabila A Elgazzar, MD

CONTACT

00201288585733; nabilaelgazzar@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Locations

EG (1)