Preventive endoscopic banding for high-risk esophageal varices in people with hepatocellular carcinoma starting atezolizumab plus bevacizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study will perform prophylactic endoscopic variceal ligation (EVL) within two weeks before starting atezolizumab plus bevacizumab in patients with HCC and high-risk esophageal varices. Participants will receive standard Atezo/Bev therapy and undergo scheduled follow-up endoscopies after the 3rd, 5th, and 7th doses, with on-demand EVL if varices persist or worsen. The primary aim is to see if prophylactic EVL lowers variceal bleeding rates to levels similar to patients with low-risk varices while monitoring safety. Secondary objectives include effects on treatment continuity, survival, quality of life, and exploratory biomarker analyses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Liver cancer center, Asan Medical Center
  Seoul, Song-pa, South Korea Recruiting

Study contacts

• Study coordinator: Ju Hyun Shim, MD, PhD
• Email: s5854@amc.seoul.kr
• Phone: +82-2-3010-3190

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Carbon ion radiotherapy plus atezolizumab and bevacizumab for advanced hepatocellular carcinoma

  This trial will try adding carbon ion radiotherapy to standard atezolizumab‑bevacizumab treatment for adults with advanced hepatocellular carcinoma to see if it controls tumors better and improves survival.

  Recruiting Phase 2 Yonsei University · Seoul · NCT07246668

• Combining atezolizumab and bevacizumab with Y-90 radioembolization to help people with liver cancer get to transplant

  This trial tests whether adding immunotherapy (atezolizumab plus bevacizumab) to Y-90 radioembolization can help people with hepatocellular carcinoma bridge to or be downstaged for liver transplant.

  Recruiting Phase 4 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07059494

• Combination therapy for hepatocellular carcinoma using atezolizumab, bevacizumab, and memantine

  This study is testing a new combination of three medications to see if it can help people with advanced liver cancer feel better and improve their quality of life.

  Recruiting at 2 sites Phase 2 Inova Health Care Services · Fairfax, Virginia and 1 other locations · NCT06789757

• Combining Atezolizumab and Bevacizumab with Photon Radiotherapy for Liver Cancer

  This study is testing if combining two cancer drugs, atezolizumab and bevacizumab, with radiation therapy can help people with liver cancer that can't be surgically removed live longer and feel better.

  Recruiting Phase 2 Chang Gung Memorial Hospital · Taoyuan City, Taiwan · NCT06339424

• Valemetostat with atezolizumab and bevacizumab for advanced hepatocellular carcinoma

  This will test whether adding the oral drug valemetostat to atezolizumab and bevacizumab helps people with advanced hepatocellular carcinoma who have not received prior systemic therapy.

  Recruiting Phase 1/2 University of Alabama at Birmingham · Birmingham, Alabama · NCT06294548

• Combination treatment for advanced liver cancer with portal vein tumor invasion

  This study is testing a new combination treatment for advanced liver cancer with portal vein tumor invasion to see if it helps patients live longer compared to standard treatment.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangzhou · NCT05984511

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.