RecruitingPhase 2NCT04224636

Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab

A Randomized, 2-arm Non-comparative Phase II Study on the Efficacy of Atezolizumab and Roche Bevacizumab (Atezo/Bev) Followed by On-demand Selective TACE (sdTACE) Upon Detection of Disease Progression or of Initial Synchronous Treatment With TACE and Atezo/Bev on 24-months Survival Rate in the Treatment of Unresectable Hepatocellular Carcinoma Patients


Sponsor

Ludwig-Maximilians - University of Munich

Enrollment

106 participants

Start Date

Jun 10, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Aim of the study is to evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment sequences for liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed: starting with a combination of immunotherapy drugs (atezolizumab and bevacizumab) followed by a procedure that blocks blood supply to tumors (TACE), versus starting with TACE and adding immunotherapy when needed. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of liver cancer (HCC) - Your liver cancer cannot be cured with surgery or ablation - You are eligible for the TACE procedure - Your liver function is relatively preserved (Child-Pugh class A or B7) - You have not received prior treatment for liver cancer - Your HIV test is negative **You may NOT be eligible if...** - Your liver cancer has spread outside the liver or has grown into blood vessels - You have clinically significant fluid buildup in the abdomen (ascites) - You have had prior treatment for liver cancer (including prior TACE) - You have a history of autoimmune disease - You have had a liver or organ transplant - You are on a liver transplant waiting list 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

COMBINATION_PRODUCTAtezolizumab Injection, Bevacizumab Injection

Atezolizumab and Bevacizumab will be administered prior to or in combination with TACE


Locations(7)

University of Bonn

Bonn, Germany

University Hospital Cologne

Cologne, Germany

Hospital of the University of Munich

Munich, Germany

Klinikum Rechts der Isar of the Technical University Munich

Munich, Germany

University Hospital Regensburg

Regensburg, Germany

University Hospital Tübingen

Tübingen, Germany

Würzburg University Hospital

Würzburg, Germany

View Full Details on ClinicalTrials.gov

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NCT04224636


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