Clinical trial · Interventional
A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma
A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
NCT02004210CI-TRIAL-00021932withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants were enrolled.
Summary
Brief summary (as posted)
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| transarterial chemoembolization (TACE) | Procedure | — | UNRESOLVED |
| transarterial radioembolization (TARE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The TARE group
- description
- transarterial radioembolization group
- interventionNames
- Procedure: transarterial radioembolization (TARE)
- type
- EXPERIMENTAL
- label
- The TACE group
- description
- Transarterial chemoembolization group
- interventionNames
- Procedure: transarterial chemoembolization (TACE)
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- every 12 weeks, up to the time of death, up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC * Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment) * Patients with single large HCC or multinodular HCC * Single \& 5cm \< size \< 15cm * 2-5 nodules \& maximal sized 4-15cm \& sum of diameters ≦ 25cm * Infiltrative type \& unilobular involvement on liver MRI * Segmental or lobar portal vein invasion can be included. * Age : 20 years to 80 years * ECOG Performance Status of 0 to 2 * Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7) * Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * WBC count ≧ 1,000/mm3 * Absolute neutrophil count \> 500/mm3 * Hb ≧ 7.0 g/dL * Platelet count \> 100,000 /mm3 * Bilirubin ≦ 3 mg/dL * Adequate clotting function: INR ≦ 2.3 or ≦ 6sec Exclusion Criteria: * Child-Pugh score ≧ 8 * ECOG Performance Status ≧ 3 * Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL * History of organ allograft * Patients with uncontrolled co-morbidity which needs treatment * Patients who have received prior systemic chemotherapy * Patients who have received Capecitabine within 8 weeks * Patients with extrahepatic metastasis * Main portal vein invasion * Patients with lymph node metastasis * Bilobar involvement * Bulk disease(Tumor volume \>70% of the target liver volume, or tumor nodules too numerous to count) * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.