Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE | Procedure | — | UNRESOLVED |
| tirapazamine | Drug | — | UNRESOLVED |
| Transarterial Embolization (TAE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TATE
- description
- Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.
- interventionNames
- Drug: tirapazamine
- Procedure: Transarterial Embolization (TAE)
- type
- EXPERIMENTAL
- label
- TACE
- description
- Patients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension.
- interventionNames
- Procedure: TACE
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available