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)
Zhejiang Raygene Pharmaceuticals Co., Ltd
300 participants
Mar 27, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.
- No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.
- Patients must be eligible for TAE or TACE treatment.
- ECOG ≤ 1.
- Child-Pugh score ≤ 7.
- Adequate bone marrow, liver, and kidney function is required.
Exclusion Criteria4
- History of liver transplantation.
- Previous radioemblization or radiotherapy for liver tumors.
- severe cardiovascular or renal diseases, active systemic infections.
- Clinically significant hypoxia (oxygen saturation \< 92% without oxygen supplementation)
Interventions
Intra-arterial injection into the tumor feeding artery
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
TACE with epirubicin
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06844357