None listed
Conditions
Interventions
Procedure/Surgery : The endoscopic examination is performed by an experienced gastroenterology specialist. If high-risk esophageal varices are identified, endoscopic variceal ligation (EVL) is perform
otherwise, on-demand EVL is continued:
1) Esophageal varices have improved to F1 or lower
2) Red color sign has disappeared
The next cycle of Atezo/Bev treatment is administered 2 weeks (±1 week) af
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 19 years or older and under 80 years. 2) Patients with liver function classified as Child-Pugh class A. 3) Patients with advanced or unresectable hepatocellular carcinoma. 4) Patients with a performance status of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) performance scale. 5) Patients with adequate hematologic function, meeting the following criteria: - Hemoglobin = 9.0 g/dL - Absolute neutrophil count (ANC) = 1,000/mm³ - Platelet count = 70,000/µL - Prothrombin time (%) = 70% (or Prothrombin INR = 1.2) 6) Patients with high-risk varices confirmed by upper endoscopy within 6 months prior to the study initiation. 7) Female patients without plans to breastfeed and using contraception if of childbearing potential, or male patients without plans for their partner's pregnancy or using contraception. 8) Patients who have been informed about the purpose and methods of treatment and have agreed to participate in the treatment.
Exclusion criteria
Exclusion criteria: 1) Patients who have previously received systemic treatment for advanced hepatocellular carcinoma 2) Patients with intrahepatic tumor involvement of 50% or more. 3) Patients with tumor thrombus in the main portal vein or both first-order branches (Vp4). 4) Patients with a history of liver transplantation. 5) Patients with uncontrolled malignant tumors other than HCC at the time of enrollment (patients with at least two years of disease-free survival are eligible). 6) Patients with uncontrolled or severe underlying diseases requiring treatment. 7) Patients with a history of esophageal/gastric variceal bleeding. 8) Patients who have undergone endoscopic or radiologic treatment for esophageal/gastric varices (e.g., EVO, EVL, TIPS, PARTO, etc.). 9) Patients who have used antiplatelet agents or anticoagulants within one week prior to study initiation. 10) Patients with isolated fundic varices graded as =Grade 2 or showing a red color sign on upper endoscopy. 11) Pregnant women. 12) Patients who cannot understand the written consent or refuse to provide consent. 13) Patients deemed unsuitable for clinical research based on the investigator’s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of esophageal varix bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of esophageal variceal bleeding;Cumulative incidence of gastrointestinal bleeding excluding esophageal varices;Cumulative incidence of liver-related complications excluding esophageal variceal bleeding;Incidence of complications related to endoscopic variceal ligation ;Overall survival; Assessment of quality of life related to treatment;Exploratory blood biomarkers predicting esophageal variceal bleeding and response to Atezo/Bev treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactJiwon Yang
Asan Medical Center
Outcome results
None listed