Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
Launched by TANTA UNIVERSITY · Apr 29, 2025
Trial Information
Current as of July 06, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to prevent the worsening of esophageal varices (enlarged veins in the esophagus) in patients with advanced liver cancer (hepatocellular carcinoma) who are being treated with two specific medications called atezolizumab and bevacizumab. The researchers want to see if checking for these varices more frequently can help reduce the risk of bleeding and whether a procedure called variceal band ligation (which helps to treat small varices) can be effective before starting the new treatment.
To participate in the trial, patients need to have confirmed advanced liver cancer and good liver function. They should also have low-risk esophageal varices or none at all. Participants will undergo a series of tests, including imaging and endoscopic examinations, at the beginning of the trial and then again at 3, 6, 9, and 12 months. This study is currently recruiting participants aged 65 to 74, and it’s important to note that certain individuals, such as those with severe liver disease or other serious health issues, will not be eligible to join.
Gender
ALL
Eligibility criteria
- 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.
About Tanta University
Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tanta, Gharbyea, Egypt
Patients applied
Trial Officials
Rania M Elkafoury, MD
Principal Investigator
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported