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NCT Number: NCT06961526

Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

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).

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Key information

Conditions

Esophageal and/or Gastric Varices Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Hepatocellular Carcinoma (HCC) Hypertension, Portal Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Dina H Ziada, MD, head of department

CONTACT

[email protected]

00201117109990

Madona M Fahmy, MD

SUB_INVESTIGATOR

Nabila A Elgazzar, MD

SUB_INVESTIGATOR

Rania M Elkafoury, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. esophagogastric varices progression rate

    Time frame: 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.

  2. variceal band ligation in small varices without bleeding stigmata

    Time frame: 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 outcomes

  1. shortening the endoscopic follow-up intervals

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nabila A Elgazzar, MD

CONTACT

[email protected]

00201288585733

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Primary Prophylaxis of Esophageal Varices in Patients Treated With Atezolizumab and Bevacizumab for Advanced Hepatocellular Carcinoma.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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