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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Tanta University Hospitals
RECRUITING
Tanta
Contact Information
Primary
Rania M Elkafoury, MD
rania.elkafoury@med.tanta.edu.eg
+201004672358
Backup
Nabila A Elgazzar, MD
nabilaelgazzar@med.tanta.edu.eg
00201288585733
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2026-07
Participants
Target number of participants: 110
Treatments
Active_comparator: HCC patients with small non-risky EGVs
55 patients with small EGVs that had no red signs undergoing variceal band ligation.
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.
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov