RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
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
Locations (2)
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China
Lishui Central Hospital
Lishui, Zhejiang, China