RecruitingPhase 4NCT05185505

Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria

Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria: A Feasibility Study


Sponsor

The Methodist Hospital Research Institute

Enrollment

24 participants

Start Date

Jan 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are transplant-eligible will be treated with 6 months of neoadjuvant/downstaging atezolizumab plus bevacizumab while receiving standard of care transarterial chemoembolization (TACE). We hypothesize that atezolizumab and bevacizumab can appropriately bridge patients with HCC beyond MC to transplantation and not increase the risk of 1-year post-transplant rejection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing two immunotherapy drugs — atezolizumab and bevacizumab — in patients with liver cancer (hepatocellular carcinoma, or HCC) that is too large or advanced for standard transplant criteria. The goal is to shrink the tumor enough to make liver transplant possible. **You may be eligible if...** - You are 18 or older with liver cancer that is outside the standard size criteria for transplant - You are otherwise healthy enough to receive a liver transplant and a procedure called TACE - You have not received prior systemic therapy for liver cancer - Your liver function is adequate (Child-Pugh score A6 or better) - You test negative for HIV and active hepatitis B **You may NOT be eligible if...** - You have received prior immunotherapy or anti-cancer systemic treatment for your liver cancer - You have moderate to severe fluid buildup in your abdomen (ascites) or a history of confusion from liver disease (hepatic encephalopathy) - You have active autoimmune disease requiring systemic treatment - You have significant heart, lung, or bleeding problems - You are pregnant or breastfeeding - You have cancer that has spread outside the liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

1200 mg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period

DRUGBevacizumab

15 mg/kg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period


Locations(1)

Houston Methodist Research Institute

Houston, Texas, United States

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NCT05185505


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