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)

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.

Inclusion Criteria:

• 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 Criteria:

• 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)