NCT06844357

A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.

A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II clinical trial aims to determine the efficacy and safety of TATE compared to TACE in patients with intermediate-stage HCC. The results will provide valuable insights into the potential benefits of TATE as a novel treatment option for HCC.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	tirapazamine	Intra-arterial injection into the tumor feeding artery
PROCEDURE	Transarterial Embolization (TAE)	Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
PROCEDURE	TACE	TACE with epirubicin

Timeline

• Start date: 2025-03-27
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2025-02-25
• Last updated: 2025-04-06

Locations

2 sites across 1 country: China