Preventing esophageal varices in liver cancer patients treated with specific medications
Primary Prophylaxis of Esophageal Varices in Patients Treated With Atezolizumab and Bevacizumab for Advanced Hepatocellular Carcinoma.
This study is testing whether treating liver cancer patients with specific medications can help prevent the worsening of esophageal varices and reduce the risk of bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab |
| Locations | 1 site (Tanta, Gharbyea) |
| Trial ID | NCT06961526 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to evaluate the progression of esophageal varices in patients with hepatocellular carcinoma (HCC) who are being treated with atezolizumab and bevacizumab. The study will assess the efficacy of primary prophylaxis for small esophageal varices without risky signs and will explore the impact of shortening endoscopic follow-up intervals to mitigate the risk of variceal hemorrhage. Participants will undergo regular endoscopic examinations at 3, 6, 9, and 12 months to monitor variceal progression and may receive esophageal band ligation before starting therapy to prevent further complications.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced HCC who have preserved liver function and no or grade 1 non-risky esophageal varices.
Not a fit: Patients with Child-Pugh class C liver function or those with a performance status greater than 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of variceal bleeding in patients with HCC undergoing treatment.
How similar studies have performed: While there have been studies on esophageal varices management, this specific approach combining atezolizumab and bevacizumab therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, Gharbyea
- Tanta University Hospitals — Tanta, Gharbyea, Egypt (Recruiting)
Study contacts
- Principal investigator: Rania M Elkafoury, MD — Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.