NCT06961526 Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
| NCT ID | NCT06961526 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tanta University |
| Condition | Esophageal and/or Gastric Varices |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-02-15 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Rania M Elkafoury, MD
PRINCIPAL INVESTIGATOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Frequently Asked Questions
Who can join the NCT06961526 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal and/or Gastric Varices. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06961526 currently recruiting?
Yes, NCT06961526 is actively recruiting participants. Contact the research team at rania.elkafoury@med.tanta.edu.eg for enrollment information.
Where is the NCT06961526 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT06961526 clinical trial?
NCT06961526 is sponsored by Tanta University. The principal investigator is Rania M Elkafoury, MD at Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University. The trial plans to enroll 110 participants.