Preventive endoscopic banding for high-risk esophageal varices in people with hepatocellular carcinoma starting atezolizumab plus bevacizumab
Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezolizumab Plus Bevacizumab for Hepatocellular Carcinoma : A Phase II, Multicenter, Single-arm Trial (ESCOAT Trial)
This study will test whether doing preventive endoscopic banding of high-risk esophageal varices can reduce bleeding in people with hepatocellular carcinoma who are starting atezolizumab plus bevacizumab.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab |
| Locations | 1 site (Seoul, Song-pa) |
| Trial ID | NCT06819566 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study will perform prophylactic endoscopic variceal ligation (EVL) within two weeks before starting atezolizumab plus bevacizumab in patients with HCC and high-risk esophageal varices. Participants will receive standard Atezo/Bev therapy and undergo scheduled follow-up endoscopies after the 3rd, 5th, and 7th doses, with on-demand EVL if varices persist or worsen. The primary aim is to see if prophylactic EVL lowers variceal bleeding rates to levels similar to patients with low-risk varices while monitoring safety. Secondary objectives include effects on treatment continuity, survival, quality of life, and exploratory biomarker analyses.
Who should consider this trial
Good fit: Adults aged 19–79 with HCC who are Child-Pugh A, ECOG 0–1, have screening endoscopy–confirmed high-risk esophageal varices, and are planned for first-line atezolizumab plus bevacizumab are ideal candidates.
Not a fit: Patients with decompensated liver disease (Child-Pugh B/C), prior systemic HCC therapy, significant coagulopathy, or those without high-risk varices are unlikely to benefit from this prophylactic approach.
Why it matters
Potential benefit: If successful, prophylactic EVL could reduce variceal bleeding and help patients remain on their preferred cancer therapy without interruption.
How similar studies have performed: Endoscopic variceal ligation is an established method to prevent variceal hemorrhage in cirrhosis, but using prophylactic EVL specifically to prevent bleeding during atezolizumab–bevacizumab treatment for HCC is a novel application with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 19 years or older and under 80 years. * Patients with liver function are classified as Child-Pugh Class A. * Barcelona Clinic Liver Cancer stage C patients with no prior systemic anticancer therapy for hepatocellular carcinoma. * Patients with an Eastern Cooperative Oncology Group performance score of 0-1. * Adequate Hematologic and Liver Function: A. Hemoglobin: ≥ 9.0 g/dL B. Absolute Neutrophil Count : ≥ 1,000/mm³ C. Platelet Count: ≥ 70,000/μL D. Prothrombin Time: ≥ 70% (or Prothrombin Time INR ≤ 1.2) * Patients with upper gastrointestinal endoscopy performed within six months prior to the start of anticancer treatment. * No plans for breastfeeding, and if of childbearing potential, using contraception or no plans for spouse's pregnancy or practicing contraception. * Patients who have received an explanation of the treatment purpose and methods and have provided informed consent for the treatment. Exclusion Criteria: * Participants who have previously received systemic anticancer therapy for advanced hepatocellular carcinoma. * Patients with intrahepatic tumor involvement of 50% or more. * Patients with tumor thrombus in the main portal vein or both first-order branches (Vp4). * Patients with a prior history of liver transplantation. * with uncontrolled malignant tumors other than HCC at the time of enrollment (participation is allowed if disease-free survival exceeds two years). * Patients with uncontrolled or serious underlying diseases requiring treatment. * Patients with a history of esophageal or gastric variceal bleeding. * Previous Variceal Treatments: Patients who have undergone any of the following treatments for variceal bleeding: A. Endoscopic Variceal Obliteration (EVO) B. EVL C. Transjugular Intrahepatic Portosystemic Shunt (TIPS) D. Percutaneous Approach for Retrograde Transvenous Obliteration (PARTO) E. Surgical procedures * Patients who have used anticoagulants or antiplatelet agents within one week prior to the study. * Presence of grade 2 or higher isolated gastric varices or Red Color Signs confirmed by baseline endoscopy (EGD). * Patients who are pregnant. * Patients who are unable to understand or provide written informed consent. * Patients deemed unsuitable for clinical study participation based on the investigator's judgment.
Where this trial is running
Seoul, Song-pa
- Liver cancer center, Asan Medical Center — Seoul, Song-pa, South Korea (Recruiting)
Study contacts
- Study coordinator: Ju Hyun Shim, MD, PhD
- Email: s5854@amc.seoul.kr
- Phone: +82-2-3010-3190
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.