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A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.
Sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-03-27
Completion Date
2029-04-01
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
tirapazamine
Intra-arterial injection into the tumor feeding artery
Transarterial Embolization (TAE)
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
TACE
TACE with epirubicin
Locations (2)
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China
Lishui Central Hospital
Lishui, Zhejiang, China