Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04224636
NCT04224636
Recruiting
Phase 2

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

Ludwig-Maximilians - University of Munich7 sites in 1 country106 target enrollmentJune 10, 2020
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHepatocellular Carcinoma Non-resectable

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hepatocellular Carcinoma Non-resectable
Sponsor
Ludwig-Maximilians - University of Munich
Enrollment
106
Locations
7
Primary Endpoint
Overall response rate (ORR)
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2020
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Enrico De Toni

Professor

Ludwig-Maximilians - University of Munich

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overall response rate (ORR)

Time Frame: 24 months

Response is defined by RECIST 1.1 and mRECIST

Secondary Outcomes

  • Adverse Events(24 months)
  • Median overall survival (mOS)(24 months)
  • 24-months survival rate(24 months)
  • Time to deterioration of liver function(24 months)
  • Disease control rate (DCR)(24 months)
  • Time to first TACE (arm A)(24 months)
  • Quality of life (QOL)(24 months)
  • Time to untreatable progression(24 months)
  • Time to stage-progression(24 months)
  • Complete response rate (CRR)(24 months)
  • Progression-free survival (PFS)(24 months)

Study Sites (7)

Loading locations...

Similar Trials

Recruiting
Phase 2
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 CirrhosisHepatocellular Carcinoma
NCT06096779Genentech, Inc.30
Completed
Phase 2
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract CancerBiliary Tract Cancer
NCT04677504Hoffmann-La Roche162
Active, not recruiting
Phase 2
Atezo+Bev study for pretreated patientshepatocellular carcinoma
JPRN-jRCT1041200068Yamashita Tatsuya28
Active, not recruiting
Phase 2
Phase II study of atezolizumab plus bevacizumab combination therapy for the patients with unresectable hepatocellular carcinoma and Child-Pugh BHepatocellular carcinomaSystemic therapy
JPRN-jRCTs031210355Ikeda Masafumi30
Active, not recruiting
Phase 2
A Study of Atezolizumab and Bevacizumab in Hepatocellular CarcinomaUnresectable Hepatocellular Carcinoma
NCT04829383Howard S Hochster50