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New treatment option for Hepatocellular Carcinoma
Official title Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezo/Bev for HCC
ClinicalTrials.gov ID: NCT06819566
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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.
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Song-pa, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Song-pa, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.