Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezo/Bev for HCC

Launched by ASAN MEDICAL CENTER · Feb 8, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether a procedure called prophylactic endoscopic variceal ligation (EVL) can help prevent bleeding from enlarged veins in the esophagus (esophageal varices) in patients with liver cancer (hepatocellular carcinoma, or HCC) who are receiving a treatment combination of atezolizumab and bevacizumab, known as Atezo/Bev. The main goal is to see if this preventive treatment can lower the risk of bleeding in high-risk patients to a level similar to those considered low-risk. The study will also look at the safety of this approach.

To participate in this trial, individuals must be between 19 and 79 years old and have specific liver function criteria. They should have not received previous treatments for their liver cancer and have a good performance status, meaning they can carry out daily activities. Participants will first undergo the EVL procedure and then start the Atezo/Bev treatment a couple of weeks later. They will have follow-up endoscopies to monitor their condition after receiving the treatment doses. If their varices improve, no further treatment will be needed; if they do not, additional EVL may be performed. This trial aims to determine if prophylactic EVL should become a standard practice for managing these high-risk varices in HCC patients.

Gender

ALL

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.