Trial intelligence / Profile preview

Atezolizumab and Bevacizumab with TACE in BCLC B HCC

NCT05776875Phase 2

Key facts

Status: Terminated
Start: Jun 2023
Primary completion: Dec 2024
Countries: 1
Sponsor: Yale University
Modality: Monoclonal Antibodies

Drugs: atezolizumabbevacizumab
Conditions: hepatocellular carcinoma (HCC)

Overview

Phase 2, open-label, single-arm trial of atezolizumab and bevacizumab in hepatocellular carcinoma (HCC), sponsored by Yale University. Primary endpoint: Grade 3 or Higher Treatment Related Adverse Events at 18 months. Started Jun 2023; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Atezolizumab + Bevacizumab + TACE
Atezolizumab and Bevacizumab q3w with TACE at week 4

Who it enrols

Adult patients with BCLC B HCC, Child-Pugh A, ECOG 0-1, measurable disease, and adequate organ function. Excludes prior systemic therapy (except RFA), liver failure, and untreated varices.

Endpoints

Primary

Grade 3 or Higher Treatment Related Adverse Events18 months

Secondary

Response Rate in Solid Tumors18 months
Response Rate in Hepatocellular Carcinoma18 months
Time to Progression18 months
Time to TACE Progression18 months
Time to Untaceable Progression18 months

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