Clinical trial · Interventional
TATE Versus TACE in Intermediate Stage HCC
TATE Versus TACE, an Open-label Randomized Study Comparing TransArterial Tirapazamine Embolization Versus TransArterial ChemoEmbolization in Intermediate Stage Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Landscape changed and the study population is no longer suitable for the study treatment.
Summary
Brief summary (as posted)
An open label randomized study to compare TATE versus TACE in patients with intermediate stage Hepatocellular carcinoma who are not suitable for surgical resection or radiofrequency ablation. The primary endpoint is Progression Free Survival. Secondary endpoints including CR rate, Time to embolization failure, Duration of CR, OS, ORR, local control rate, time to local recurrence and duration to local recurrence. The study treatment is to compare Tirapazamine versus doxorubicin when combined with trans-arterial embolization. Study plans to enroll 134 patients in 1:1 randomization for TATE or TACE. MRI will be used to assess efficacy using a central radiological review for the final analysis.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Tirapazamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trans-Arterial Tirapazamine Embolization (TATE)
- description
- Patients will receive a fixed dose of Tirapazamine combined with embolization using Lipiodol and Gelfoam.
- interventionNames
- Drug: Tirapazamine
- type
- ACTIVE_COMPARATOR
- label
- Trans-Arterial ChemoEmbolization (TACE)
- description
- Patients will receive a mixture of doxorubicin and Lipiodol into the tumor feeding artery followed by injection of Gelfoam to induce embolization per standard procedure.
- interventionNames
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
1. Confirmed diagnosis of HCC by imaging criteria per American Association for the Study of Liver Diseases (AASLD) criteria. 2. Patients with single or multiple HCC who are unsuitable for surgical resection or RFA, but suitable for embolization. 3. ECOG score 0-1. Child-Pugh score up to B7. 4. Patients should have measurable tumor lesion(s) by contrast MRI. 5. Patients have adequate normal organ function and suitable laboratory criteria. 6. Men and women of child-bearing age need to commit to using two levels of contraception simultaneously to avoid pregnancy. Exclusion Criteria: 1. Patients who have had a liver transplantation. 2. Patients who have uncontrolled major medical problems such as cardiac, pulmonary (COPD requiring constant oxygen), renal (creatinine over 2.0) diseases, active infectious diseases (except chronic Hepatitis B or C), or non-healing ulceration. 3. Patients who have any clinical evidence of hypoxia with O2 saturation less than 92% on room air. 4. Patients with evidence of arterial insufficiency or microangiopathy in any organ due to any reason, which could lead to distal extremity hypoxia, as evidenced by any gangrenous change in distal limbs or requiring resection for this reason. 5. Patients with poorly controlled HBV infection. 6. Patients on interferon treatment need to have at least 2-week washout period from Day 1. 7. Patients with major gastrointestinal bleeding in the prior 2 months of enrollment or known diagnosis of cancer other than HCC. 8. Pregnant or lactating women.
References
Publications (0)
Data not yet available