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

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable

• Registration Number: NCT04224636
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-06-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	24 months	Response is defined by RECIST 1.1 and mRECIST

Secondary Outcome Measures

Name	Time	Method
Median overall survival (mOS)	24 months	Defined as the time from treatment initiation until death
24-months survival rate	24 months	Percentage of patients alive after 24 months since randomization
Time to deterioration of liver function	24 months	Defined as time from randomization to worsening of CTCAE grade for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR)
Disease control rate (DCR)	24 months	Defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time to first TACE (arm A)	24 months	Defined as time from randomization to disease to the first TACE
Quality of life (QOL)	24 months	Standardized assessment will be performed by using EORTC QLQ-HCC18 - European Organisation for Research and Treatment of Cancer - Quality of Life Core Questionnaire - Hepatocellular carcinoma module 18
Time to untreatable progression	24 months	defined as time from randomization to progression not amenable to local treatment as per protocol, occurrence of vascular invasion or of extrahepatic spread, worsening of liver function to Child-Pugh score 8 or higher
Time to stage-progression	24 months	Defined as time from randomization to disease progression to BCLC C stage
Complete response rate (CRR)	24 months	Defined by the percentage of patients with disappearance of tumor manifestation at radiological evaluation
Adverse Events	24 months	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Progression-free survival (PFS)	24 months	Progression is defined according RECIST 1.1 and mRECIST

Trial Locations

Locations (7)

University of Bonn; 🇩🇪 Bonn, Germany

University Hospital Cologne; 🇩🇪 Köln, 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