Trial intelligence / Profile preview

REGONEXT: Regorafenib in HCC after Atezolizumab/Bevacizumab

NCT05134532Phase 2

Key facts

Status: Unknown
Start: Dec 2021
Primary completion: Oct 2024
Countries: 1
Sponsor: CHA University
Modality: Small Molecules

Drugs: regorafenib
Conditions: hepatocellular carcinoma (HCC)

Overview

Phase 2, open-label, single-arm trial of regorafenib in hepatocellular carcinoma (HCC), sponsored by CHA University. Primary endpoint: Progression-Free Survival up to 36 months. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

Regorafenib Arm
Patients receive Regorafenib 160 mg daily for 3 weeks of every 4-week cycle.

Who it enrols

Patients with unresectable HCC who have progressed on first-line atezolizumab plus bevacizumab, with Child-Pugh A liver function and ECOG 0-1.

Endpoints

Primary

Progression-Free Survivalup to 36 months

Secondary

Overall Survivalup to 36 months
Time to Progressionup to 36 months
Overall Response Rateup to 36 months
Disease Control Rateup to 36 months
Safety Profilesup to 36 months

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