- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06961526
Preventing Esophageal Varices in Advanced Liver Cancer Patients on Atezolizumab-Bevacizumab Therapy
This clinical trial investigates the effectiveness of esophageal band ligation as primary prophylaxis against variceal progression in advanced hepatocellular carcinoma (HCC) patients receiving atezolizumab-bevacizumab combination therapy. The study aims to determine whether early intervention with endoscopic banding can reduce the risk of life-threatening variceal bleeding in this high-risk population.
Study Design: This randomized controlled trial will enroll 110 adult patients with compensated liver disease (Child-Pugh A) who are initiating atezolizumab-bevacizumab treatment. Participants will be divided into two arms:
- Intervention Arm: 55 patients with small non-risky esophageal/gastric varices will undergo prophylactic band ligation before starting cancer therapy, with follow-up endoscopies at 3, 5, 9, and 12 months
- Control Arm: 55 patients with no or minimal varices will receive standard surveillance without prophylactic intervention
Primary Outcomes: The research team will evaluate:
- Rate of esophagogastric varices progression during systemic therapy
- Effectiveness of band ligation in preventing variceal bleeding
Secondary Outcome: The study will assess whether more frequent endoscopic monitoring can improve bleeding prevention in patients receiving this specific immunotherapy combination.
Rationale: Patients with HCC often have portal hypertension and are at risk for variceal bleeding, which may be exacerbated by bevacizumab's anti-angiogenic effects. This study addresses a critical gap in managing vascular complications during novel cancer therapies.
Exclusion Criteria: The trial excludes patients with decompensated cirrhosis (Child-Pugh C), significant comorbidities, or poor performance status. The research team anticipates completing enrollment and follow-up within approximately 18 months.