Clinical trial NCT06961526: Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
Official title: Primary Prophylaxis of Esophageal Varices in Patients Treated With Atezolizumab and Bevacizumab for Advanced Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal and/or Gastric Varices
Hepatocellular Carcinoma (HCC)
Keywords: Esophageal varices
hepatocellular carcinoma
atezolizumab-bevacizumab therapy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: esophagogastric varices progression rate
timeFrame: through study completion, an average of 1 year
measure: variceal band ligation in small varices without bleeding stigmata
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: shortening the endoscopic follow-up intervals
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbyea
Study officials:
affiliation: Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
name: Rania M Elkafoury, MD
role: PRINCIPAL_INVESTIGATOR
References: