NCT06819566 Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezo/Bev for HCC
| NCT ID | NCT06819566 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Asan Medical Center |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 44 participants in total. It began in 2025-05-28 with a primary completion date of 2026-12-31.
⚠ 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 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.
Eligibility 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.
Contact & Investigator
Jihyun An, MD, PhD
STUDY DIRECTOR
Gastroenterology and Hepatology, Hanyang University College of Medicine, Guri, Republic of Korea
Frequently Asked Questions
Who can join the NCT06819566 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06819566 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06819566 currently recruiting?
Yes, NCT06819566 is actively recruiting participants. Contact the research team at s5854@amc.seoul.kr for enrollment information.
Where is the NCT06819566 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06819566 clinical trial?
NCT06819566 is sponsored by Asan Medical Center. The principal investigator is Jihyun An, MD, PhD at Gastroenterology and Hepatology, Hanyang University College of Medicine, Guri, Republic of Korea. The trial plans to enroll 44 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.