Actively Recruiting
Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezo/Bev for HCC
Led by Asan Medical Center · Updated on 2025-07-24
44
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to evaluate whether prophylactic endoscopic variceal ligation (EVL) can prevent esophageal variceal bleeding in patients with hepatocellular carcinoma (HCC) receiving atezolizumab and bevacizumab (Atezo/Bev) therapy. The study will also assess the safety of prophylactic EVL in this population. The main question it aims to answer is: Does prophylactic EVL in high-risk varices reduce the incidence of variceal bleeding to a level similar to that of low-risk varices in HCC patients receiving Atezo/Bev? Participants will: 1. Undergo prophylactic EVL before starting Atezo/Bev therapy (within 2 weeks ± 1 week before the first dose). 2. Start Atezo/Bev therapy 2 weeks (± 1 week) after EVL. 3. Have follow-up endoscopies (EGD) one week after the 3rd, 5th, and 7th doses of Atezo/Bev. If varices improve, no additional intervention is needed. If varices persist or worsen, on-demand EVL will be performed, and Atezo/Bev will continue. This study will help determine if prophylactic EVL should be a standard strategy for managing high-risk varices in HCC patients undergoing Atezo/Bev therapy.
CONDITIONS
Official Title
Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezo/Bev for HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older and under 80 years.
- Liver function classified as Child-Pugh Class A.
- Barcelona Clinic Liver Cancer stage C with no prior systemic anticancer therapy for hepatocellular carcinoma.
- Eastern Cooperative Oncology Group performance score of 0-1.
- Adequate blood and liver function: Hemoglobin 8.0 g/dL, Absolute Neutrophil Count 1,000/mm6,000/bcL, Prothrombin Time 70% or INR 1.2.
- Upper gastrointestinal endoscopy performed within six months before starting anticancer treatment.
- Not breastfeeding, and using contraception or no plans for pregnancy if of childbearing potential.
- Provided informed consent after receiving treatment explanation.
You will not qualify if you...
- Prior systemic anticancer therapy for advanced hepatocellular carcinoma.
- Intrahepatic tumor involvement of 50% or more.
- Tumor thrombus in the main portal vein or both first-order branches (Vp4).
- History of liver transplantation.
- Uncontrolled malignant tumors other than HCC unless disease-free for over two years.
- Uncontrolled or serious underlying diseases needing treatment.
- History of esophageal or gastric variceal bleeding.
- Previous variceal treatments like Endoscopic Variceal Obliteration, EVL, TIPS, PARTO, or surgery.
- Use of anticoagulants or antiplatelet agents within one week before the study.
- Presence of grade 2 or higher isolated gastric varices or Red Color Signs on baseline endoscopy.
- Pregnancy.
- Unable to understand or provide written informed consent.
- Deemed unsuitable for study participation by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Liver cancer center, Asan Medical Center
Seoul, Song-pa, South Korea, 05505
Actively Recruiting
Research Team
J
Ju Hyun Shim, MD, PhD
CONTACT
J
Jiwon Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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